Matthew Meyerson / en Thu, 20 Nov 25 09:50:31 -0500 FDA approves first cancer drug based on ӳý science /news/fda-approves-first-cancer-drug-based-broad-institute-science <span class="field field--name-title field--type-string field--label-hidden"><h1>FDA approves first cancer drug based on ӳý science</h1> </span> <span class="field field--name-uid field--type-entity-reference field--label-hidden"> <span>By Karen Zusi-Tran</span> </span> <span class="field field--name-created field--type-created field--label-hidden"><time datetime="2025-11-20T09:50:31-05:00" class="datetime">November 20, 2025</time> </span> <div class="hero-section container"> <div class="hero-section__row row"> <div class="hero-section__content hero-section__content_left col-6"> <div class="hero-section__breadcrumbs"> <div class="block block-system block-system-breadcrumb-block"> <nav class="breadcrumb" role="navigation" aria-labelledby="system-breadcrumb"> <h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2> <ol> <li> <a href="/">Home</a> </li> <li> <a href="/news">News</a> </li> </ol> </nav> </div> </div> <div class="hero-section__title"> <div class="block block-layout-builder block-field-blocknodelong-storytitle"> <span class="field field--name-title field--type-string field--label-hidden"><h1>FDA approves first cancer drug based on ӳý science</h1> </span> </div> </div> <div class="hero-section__description"> <div class="block block-layout-builder block-field-blocknodelong-storybody"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>Collaboration between ӳý and Bayer leads to new treatment for a hard-to-treat type of lung cancer.</p> </div> </div> </div> <div class="hero-section__author"> <div class="block block-layout-builder block-extra-field-blocknodelong-storyextra-field-author-custom"> By Karen Zusi-Tran </div> </div> <div class="hero-section__date"> <div class="block block-layout-builder block-field-blocknodelong-storycreated"> <span class="field field--name-created field--type-created field--label-hidden"><time datetime="2025-11-20T09:50:31-05:00" title="Thursday, November 20, 2025 - 09:50" class="datetime">November 20, 2025</time> </span> </div> </div> </div> <div class="hero-section__right col-6"> <div class="hero-section__image"> <div class="block block-layout-builder block-field-blocknodelong-storyfield-image"> <div class="field field--name-field-image field--type-entity-reference field--label-hidden field__item"> <article class="media media--type-image media--view-mode-multiple-content-types-header"> <div class="field field--name-field-media-image field--type-image field--label-hidden field__item"> <picture> <source srcset="/files/styles/multiple_ct_header_desktop_xl/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=za47u2EX 1x" media="all and (min-width: 1921px)" type="image/png" width="754" height="503"/> <source srcset="/files/styles/multiple_ct_header_desktop_xl/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=za47u2EX 1x" media="all and (min-width: 1601px) and (max-width: 1920px)" type="image/png" width="754" height="503"/> <source srcset="/files/styles/multiple_ct_header_desktop/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=qq1nnfil 1x" media="all and (min-width: 1340px) and (max-width: 1600px)" type="image/png" width="736" height="520"/> <source srcset="/files/styles/multiple_ct_header_laptop/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=fQR_oxNv 1x" media="all and (min-width: 800px) and (max-width: 1339px)" type="image/png" width="641" height="451"/> <source srcset="/files/styles/multiple_ct_header_tablet/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=fI861yC8 1x" media="all and (min-width: 540px) and (max-width: 799px)" type="image/png" width="706" height="417"/> <source srcset="/files/styles/multiple_ct_header_phone/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=4SKwFCKF 1x" media="all and (max-width: 539px)" type="image/png" width="499" height="294"/> <img loading="eager" width="499" height="294" src="/files/styles/multiple_ct_header_phone/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=4SKwFCKF" alt="A graphic displaying two DNA strands, a container of white pills, and the outline of a human body with lungs highlighted." title="A graphic displaying two DNA strands, a container of white pills, and the outline of a human body with lungs highlighted." typeof="foaf:Image" /> </picture> </div> <div class="media-caption"> <div class="media-caption__credit"> Credit: Agnieszka Grosso, ӳý Communications </div> <div class="media-caption__description"> Collaboration between ӳý and Bayer leads to new treatment for a hard-to-treat type of lung cancer. </div> </div> </article> </div> </div> </div> </div> </div> </div> <div class="content-section container"> <div class="content-section__main"> <div class="block block-better-social-sharing-buttons block-social-sharing-buttons-block"> <div style="display: none"><link rel="preload" href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg" as="image" type="image/svg+xml" crossorigin="anonymous" /></div> <div class="social-sharing-buttons"> <a href="https://www.facebook.com/sharer/sharer.php?u=/taxonomy/term/2676/feed&title=" target="_blank" title="Share to Facebook" aria-label="Share to Facebook" class="social-sharing-buttons-button share-facebook" rel="noopener"> <svg aria-hidden="true" width="32px" height="32px" style="border-radius:100%;"> <use href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg#facebook" /> </svg> </a> <a href="https://twitter.com/intent/tweet?text=+/taxonomy/term/2676/feed" target="_blank" title="Share to X" aria-label="Share to X" class="social-sharing-buttons-button share-x" rel="noopener"> <svg aria-hidden="true" width="32px" height="32px" style="border-radius:100%;"> <use href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg#x" /> </svg> </a> <a href="mailto:?subject=&body=/taxonomy/term/2676/feed" title="Share to Email" aria-label="Share to Email" class="social-sharing-buttons-button share-email" target="_blank" rel="noopener"> <svg aria-hidden="true" width="32px" height="32px" style="border-radius:100%;"> <use href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg#email" /> </svg> </a> </div> </div> <div class="block block-layout-builder block-field-blocknodelong-storyfield-content-paragraphs"> <div class="field field--name-field-content-paragraphs field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--text-narrow paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-text field--type-text-long field--label-hidden field__item"><div class="clearfix" style="font-family:Open Sans;background-color:#f3f3f3;padding:2em;margin-bottom:2em;"> <h3>Highlights</h3> <ul> <li aria-level="1">The new medicine, sevabertinib, is a pill approved for a type of lung cancer that previously had few treatment options. </li> <li aria-level="1">Genetic discoveries from ӳý scientists laid the foundation for the development of the drug.</li> <li aria-level="1">This FDA approval is an important milestone for the ӳý, demonstrating that research by academic scientists and close collaborations with industry can lead to benefits for patients.</li> </ul> </div> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--text-with-sidebar text-with-sidebar"> <div class="field field--name-field-sidebar field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div 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hard-to-treat type of lung cancer</span> </a> </div> </article> </div> <div class="field__item"><article about="/news/bayer-and-broad-institute-extend-cancer-therapy-research-collaboration" class="node"> <div class="field field--name-field-image field--type-entity-reference field--label-hidden field__item"><article class="media media--type-image media--view-mode-multiple-ct-sidebar-link-with-image"> <div class="field field--name-field-media-image field--type-image field--label-hidden field__item"> <a href="/news/bayer-and-broad-institute-extend-cancer-therapy-research-collaboration"><picture> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop_xl/public/Generic-ӳý-image-2.jpg?itok=Gd6Dp_hF 1x" media="all and (min-width: 1921px)" type="image/jpeg" width="104" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop_xl/public/Generic-ӳý-image-2.jpg?itok=Gd6Dp_hF 1x" media="all and (min-width: 1601px) and (max-width: 1920px)" type="image/jpeg" width="104" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop/public/Generic-ӳý-image-2.jpg?itok=Tqe-BJ1V 1x" media="all and (min-width: 1340px) and (max-width: 1600px)" type="image/jpeg" width="87" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop/public/Generic-ӳý-image-2.jpg?itok=Tqe-BJ1V 1x" media="all and (min-width: 800px) and (max-width: 1339px)" type="image/jpeg" width="87" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_tablet/public/Generic-ӳý-image-2.jpg?itok=-hwGrOz0 1x" media="all and (min-width: 540px) and (max-width: 799px)" type="image/jpeg" width="285" height="186"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_phone/public/Generic-ӳý-image-2.jpg?itok=NLf1-6yt 1x" media="all and (max-width: 539px)" type="image/jpeg" width="220" height="186"/> <img loading="eager" width="220" height="186" 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class="node__content"> <a href="/news/bayer-broad-expand-partnership-advance-cancer-drug-discovery-research" class="node__title"><span class="field field--name-title field--type-string field--label-hidden">Bayer, ӳý expand partnership to advance cancer drug discovery research</span> </a> </div> </article> </div> <div class="field__item"><article about="/news/broad-institute-and-bayer-join-forces-develop-novel-treatment-options-cancer-therapy" class="node"> <div class="node__content"> <a href="/news/broad-institute-and-bayer-join-forces-develop-novel-treatment-options-cancer-therapy" class="node__title"><span class="field field--name-title field--type-string field--label-hidden">ӳý and Bayer join forces to develop novel treatment options in cancer therapy</span> </a> </div> </article> </div> </div> </div> </div> </div> </div> <div class="clearfix text-formatted field field--name-field-text field--type-text-long field--label-hidden field__item"><p>The US Food and Drug Administration has approved the first cancer drug based on discoveries from ӳý scientists. The drug, sevabertinib, was developed by Bayer Healthcare Pharmaceuticals in close collaboration with the ӳý, and is the first FDA-approved medicine from the long-standing ӳý-Bayer oncology research alliance.</p> <p>Sevabertinib is a new oral treatment option for a type of non-small-cell lung cancer, the most common type of lung cancer. The medicine is a pill that patients can take at home and is approved for adult patients with certain <em>HER2</em> mutations in their tumors and who have already received chemotherapy or immunotherapy. This translates to roughly 4,000 to 8,000 lung cancer patients in the US every year who could potentially benefit from this new drug. Many of these patients are women, including younger women who have never smoked.</p> <p>The drug's approval is based on data from Bayer’s Phase I/II clinical trial, which found that over 70 percent of the patients studied in one cohort saw their tumors shrink or disappear. Many patients experienced profound and durable responses.</p> <p>This achievement is the result of discoveries made by ӳý scientists two decades ago and of the collaboration between ӳý and Bayer Pharmaceuticals, <a href="/news/broad-institute-and-bayer-join-forces-develop-novel-treatment-options-cancer-therapy">which began in 2013</a>. The team's clinical success demonstrates that long-term academic-industry partnerships can close the gap between biological discoveries and new medicines that improve health.</p> <p>"The whole idea of the ӳý when it was founded more than 20 years ago was to bring the power of human genome science and high-throughput research to solving human disease," said <a href="/bios/matthew-meyerson">Matthew Meyerson</a>, a lead cancer biologist on the project, institute member at the ӳý, the Charles A. Dana Chair in Human Cancer Genetics at Dana-Farber Cancer Institute, and professor of genetics and medicine at Dana-Farber and Harvard Medical School. "Today, with our industry partners at Bayer, we're now able to see the fruits of these efforts in a new drug that we hope can help many patients by extending their lifespan and improving their quality of life."</p> <h2>New option for lung cancer patients</h2> <p>Lung cancer is the leading cause of cancer-related deaths in the US, and non-small-cell lung cancer (NSCLC) accounts for more than 85 percent of lung cancer cases. Up to 4 percent of NSCLC cases carry a <em>HER2</em> gene mutation, which causes the HER2 protein to become overactive and spur abnormal cell growth.</p> <p>Sevabertinib halts the activity of HER2 proteins with certain mutations, inhibiting the growth of tumors. Approved as a second-line treatment, it may serve a patient population that until recently had no remaining options after chemotherapy or immunotherapy for treating their cancer.</p> <p>The FDA granted sevabertinib a <a href="https://www.bayer.com/media/en-us/bayer-receives-us-fda-breakthrough-therapy-designation-for-bay-2927088-for-non-small-cell-lung-cancer-harboring-her2-activating-mutations/">Breakthrough Therapy designation</a> in 2024, signifying that the compound may provide substantial improvement over existing therapies in an area of high unmet medical need. In 2025, sevabertinib was additionally <a href="https://www.bayer.com/en/us/news-stories/sevabertinib">granted Priority Review status</a>, meaning the FDA would aim to take action on an application within six months (compared to ten months under standard review).</p> <h2>A research success story</h2> <p>This milestone began with work <a href="https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020313">first published in 2005</a> led by Meyerson and <a href="/bios/heidi-greulich">Heidi Greulich</a>, an institute scientist and senior group leader in the Cancer Program at the ӳý.</p> <p>In 2005, the ӳý team reported that some lung cancer patients who didn't respond to existing drugs had a mutation in their tumors known as an “exon 20 insertion” — an extra bit of DNA tucked in at a specific location in the gene <em>EGFR</em>. Developing a drug to target this mutation was one of the first projects for the ӳý-Bayer alliance when it launched in 2013, and the work soon evolved into creating a drug to target a similar mutation in <em>HER2</em>, a gene closely related to <em>EGFR</em> that’s involved in lung and other cancers.</p> <p>"We've been collaborating closely with the Bayer team on sevabertinib and its precursor compounds for 12 years now,” said Greulich. “It really shows how the power of persistence can be brought to bear on difficult problems to help patients."</p> <p>A Phase III clinical trial is continuing to evaluate sevabertinib as a first-line treatment option for patients with NSCLC carrying <em>HER2</em> mutations. The drug is also being studied in patients with other metastatic or unresectable solid tumors, beyond lung cancer, that have <em>HER2</em> mutations.</p> <p>"We're in an extraordinary time for the development of new medicines to treat cancer patients," said Meyerson. "And I think that, with our industry partners, we have a huge opportunity to repeat this success not once, not twice, but many, many times over."</p> </div> </div> </div> </div> </div> </div> </div> <div class="content-section container"> <div class="content-section__main"> <div class="block-node-broad-tags block block-layout-builder block-field-blocknodelong-storyfield-broad-tags"> <div class="block-node-broad-tags__row"> <div class="block-node-broad-tags__title">Tags:</div> <div class="field field--name-field-broad-tags field--type-entity-reference field--label-hidden field__items"> <div class="field__item"><a href="/broad-tags/industrial-partnerships" hreflang="en">Industrial partnerships</a></div> <div class="field__item"><a href="/broad-tags/cancer" hreflang="en">Cancer</a></div> <div class="field__item"><a href="/broad-tags/matthew-meyerson" hreflang="en">Matthew Meyerson</a></div> </div> </div> </div> </div> </div> Thu, 20 Nov 2025 14:50:31 +0000 kzusi@broadinstitute.org 5559731 at Q&A: How an academic-industry alliance is reshaping the way research can lead to new medicines /news/how-academic-industry-alliance-reshaping-way-research-can-lead-new-medicines <span class="field field--name-title field--type-string field--label-hidden"><h1>FDA approves first cancer drug based on ӳý science</h1> </span> <span class="field field--name-uid field--type-entity-reference field--label-hidden"> <span>By Karen Zusi-Tran</span> </span> <span class="field field--name-created field--type-created field--label-hidden"><time datetime="2025-11-20T09:50:31-05:00" class="datetime">November 20, 2025</time> </span> <div class="hero-section container"> <div class="hero-section__row row"> <div class="hero-section__content hero-section__content_left col-6"> <div class="hero-section__breadcrumbs"> <div class="block block-system block-system-breadcrumb-block"> <nav class="breadcrumb" role="navigation" aria-labelledby="system-breadcrumb"> <h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2> <ol> <li> <a href="/">Home</a> </li> <li> <a href="/news">News</a> </li> </ol> </nav> </div> </div> <div class="hero-section__title"> <div class="block block-layout-builder block-field-blocknodelong-storytitle"> <span class="field field--name-title field--type-string field--label-hidden"><h1>FDA approves first cancer drug based on ӳý science</h1> </span> </div> </div> <div class="hero-section__description"> <div class="block block-layout-builder block-field-blocknodelong-storybody"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>Collaboration between ӳý and Bayer leads to new treatment for a hard-to-treat type of lung cancer.</p> </div> </div> </div> <div class="hero-section__author"> <div class="block block-layout-builder block-extra-field-blocknodelong-storyextra-field-author-custom"> By Karen Zusi-Tran </div> </div> <div class="hero-section__date"> <div class="block block-layout-builder block-field-blocknodelong-storycreated"> <span class="field field--name-created field--type-created field--label-hidden"><time datetime="2025-11-20T09:50:31-05:00" title="Thursday, November 20, 2025 - 09:50" class="datetime">November 20, 2025</time> </span> </div> </div> </div> <div class="hero-section__right col-6"> <div class="hero-section__image"> <div class="block block-layout-builder block-field-blocknodelong-storyfield-image"> <div class="field field--name-field-image field--type-entity-reference field--label-hidden field__item"> <article class="media media--type-image media--view-mode-multiple-content-types-header"> <div class="field field--name-field-media-image field--type-image field--label-hidden field__item"> <picture> <source srcset="/files/styles/multiple_ct_header_desktop_xl/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=za47u2EX 1x" media="all and (min-width: 1921px)" type="image/png" width="754" height="503"/> <source srcset="/files/styles/multiple_ct_header_desktop_xl/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=za47u2EX 1x" media="all and (min-width: 1601px) and (max-width: 1920px)" type="image/png" width="754" height="503"/> <source srcset="/files/styles/multiple_ct_header_desktop/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=qq1nnfil 1x" media="all and (min-width: 1340px) and (max-width: 1600px)" type="image/png" width="736" height="520"/> <source srcset="/files/styles/multiple_ct_header_laptop/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=fQR_oxNv 1x" media="all and (min-width: 800px) and (max-width: 1339px)" type="image/png" width="641" height="451"/> <source srcset="/files/styles/multiple_ct_header_tablet/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=fI861yC8 1x" media="all and (min-width: 540px) and (max-width: 799px)" type="image/png" width="706" height="417"/> <source srcset="/files/styles/multiple_ct_header_phone/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=4SKwFCKF 1x" media="all and (max-width: 539px)" type="image/png" width="499" height="294"/> <img loading="eager" width="499" height="294" src="/files/styles/multiple_ct_header_phone/public/longstory/News_ӳý-Buyer_Drug_Options_v4.png?itok=4SKwFCKF" alt="A graphic displaying two DNA strands, a container of white pills, and the outline of a human body with lungs highlighted." title="A graphic displaying two DNA strands, a container of white pills, and the outline of a human body with lungs highlighted." typeof="foaf:Image" /> </picture> </div> <div class="media-caption"> <div class="media-caption__credit"> Credit: Agnieszka Grosso, ӳý Communications </div> <div class="media-caption__description"> Collaboration between ӳý and Bayer leads to new treatment for a hard-to-treat type of lung cancer. </div> </div> </article> </div> </div> </div> </div> </div> </div> <div class="content-section container"> <div class="content-section__main"> <div class="block block-better-social-sharing-buttons block-social-sharing-buttons-block"> <div style="display: none"><link rel="preload" href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg" as="image" type="image/svg+xml" crossorigin="anonymous" /></div> <div class="social-sharing-buttons"> <a href="https://www.facebook.com/sharer/sharer.php?u=/taxonomy/term/2676/feed&title=" target="_blank" title="Share to Facebook" aria-label="Share to Facebook" class="social-sharing-buttons-button share-facebook" rel="noopener"> <svg aria-hidden="true" width="32px" height="32px" style="border-radius:100%;"> <use href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg#facebook" /> </svg> </a> <a href="https://twitter.com/intent/tweet?text=+/taxonomy/term/2676/feed" target="_blank" title="Share to X" aria-label="Share to X" class="social-sharing-buttons-button share-x" rel="noopener"> <svg aria-hidden="true" width="32px" height="32px" style="border-radius:100%;"> <use href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg#x" /> </svg> </a> <a href="mailto:?subject=&body=/taxonomy/term/2676/feed" title="Share to Email" aria-label="Share to Email" class="social-sharing-buttons-button share-email" target="_blank" rel="noopener"> <svg aria-hidden="true" width="32px" height="32px" style="border-radius:100%;"> <use href="/modules/contrib/better_social_sharing_buttons/assets/dist/sprites/social-icons--no-color.svg#email" /> </svg> </a> </div> </div> <div class="block block-layout-builder block-field-blocknodelong-storyfield-content-paragraphs"> <div class="field field--name-field-content-paragraphs field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--text-narrow paragraph--view-mode--default"> <div class="clearfix text-formatted field field--name-field-text field--type-text-long field--label-hidden field__item"><div class="clearfix" style="font-family:Open Sans;background-color:#f3f3f3;padding:2em;margin-bottom:2em;"> <h3>Highlights</h3> <ul> <li aria-level="1">The new medicine, sevabertinib, is a pill approved for a type of lung cancer that previously had few treatment options. </li> <li aria-level="1">Genetic discoveries from ӳý scientists laid the foundation for the development of the drug.</li> <li aria-level="1">This FDA approval is an important milestone for the ӳý, demonstrating that research by academic scientists and close collaborations with industry can lead to benefits for patients.</li> </ul> </div> </div> </div> </div> <div class="field__item"> <div class="paragraph paragraph--type--text-with-sidebar text-with-sidebar"> <div class="field field--name-field-sidebar field--type-entity-reference-revisions field--label-hidden field__items"> <div class="field__item"> <div class="paragraph paragraph--type--sidebar-articles sidebar-articles"> <div class="sidebar-articles__col"> <div class="clearfix text-formatted field field--name-field-heading field--type-text field--label-hidden field__item"><p>Related News</p> </div> <div class="field field--name-field-content-reference field--type-entity-reference field--label-hidden field__items"> <div class="field__item"><article about="/news/how-academic-industry-alliance-reshaping-way-research-can-lead-new-medicines" class="node"> <div class="field field--name-field-image field--type-entity-reference field--label-hidden field__item"><article class="media media--type-image media--view-mode-multiple-ct-sidebar-link-with-image"> <div class="field field--name-field-media-image field--type-image field--label-hidden field__item"> <a href="/news/how-academic-industry-alliance-reshaping-way-research-can-lead-new-medicines"><picture> <source 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hard-to-treat type of lung cancer</span> </a> </div> </article> </div> <div class="field__item"><article about="/news/bayer-and-broad-institute-extend-cancer-therapy-research-collaboration" class="node"> <div class="field field--name-field-image field--type-entity-reference field--label-hidden field__item"><article class="media media--type-image media--view-mode-multiple-ct-sidebar-link-with-image"> <div class="field field--name-field-media-image field--type-image field--label-hidden field__item"> <a href="/news/bayer-and-broad-institute-extend-cancer-therapy-research-collaboration"><picture> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop_xl/public/Generic-ӳý-image-2.jpg?itok=Gd6Dp_hF 1x" media="all and (min-width: 1921px)" type="image/jpeg" width="104" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop_xl/public/Generic-ӳý-image-2.jpg?itok=Gd6Dp_hF 1x" media="all and (min-width: 1601px) and (max-width: 1920px)" type="image/jpeg" width="104" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop/public/Generic-ӳý-image-2.jpg?itok=Tqe-BJ1V 1x" media="all and (min-width: 1340px) and (max-width: 1600px)" type="image/jpeg" width="87" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_desktop/public/Generic-ӳý-image-2.jpg?itok=Tqe-BJ1V 1x" media="all and (min-width: 800px) and (max-width: 1339px)" type="image/jpeg" width="87" height="104"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_tablet/public/Generic-ӳý-image-2.jpg?itok=-hwGrOz0 1x" media="all and (min-width: 540px) and (max-width: 799px)" type="image/jpeg" width="285" height="186"/> <source srcset="/files/styles/multiple_ct_sidebar_link_with_image_phone/public/Generic-ӳý-image-2.jpg?itok=NLf1-6yt 1x" media="all and (max-width: 539px)" type="image/jpeg" width="220" height="186"/> <img loading="eager" width="220" height="186" 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class="node__content"> <a href="/news/bayer-broad-expand-partnership-advance-cancer-drug-discovery-research" class="node__title"><span class="field field--name-title field--type-string field--label-hidden">Bayer, ӳý expand partnership to advance cancer drug discovery research</span> </a> </div> </article> </div> <div class="field__item"><article about="/news/broad-institute-and-bayer-join-forces-develop-novel-treatment-options-cancer-therapy" class="node"> <div class="node__content"> <a href="/news/broad-institute-and-bayer-join-forces-develop-novel-treatment-options-cancer-therapy" class="node__title"><span class="field field--name-title field--type-string field--label-hidden">ӳý and Bayer join forces to develop novel treatment options in cancer therapy</span> </a> </div> </article> </div> </div> </div> </div> </div> </div> <div class="clearfix text-formatted field field--name-field-text field--type-text-long field--label-hidden field__item"><p>The US Food and Drug Administration has approved the first cancer drug based on discoveries from ӳý scientists. The drug, sevabertinib, was developed by Bayer Healthcare Pharmaceuticals in close collaboration with the ӳý, and is the first FDA-approved medicine from the long-standing ӳý-Bayer oncology research alliance.</p> <p>Sevabertinib is a new oral treatment option for a type of non-small-cell lung cancer, the most common type of lung cancer. The medicine is a pill that patients can take at home and is approved for adult patients with certain <em>HER2</em> mutations in their tumors and who have already received chemotherapy or immunotherapy. This translates to roughly 4,000 to 8,000 lung cancer patients in the US every year who could potentially benefit from this new drug. Many of these patients are women, including younger women who have never smoked.</p> <p>The drug's approval is based on data from Bayer’s Phase I/II clinical trial, which found that over 70 percent of the patients studied in one cohort saw their tumors shrink or disappear. Many patients experienced profound and durable responses.</p> <p>This achievement is the result of discoveries made by ӳý scientists two decades ago and of the collaboration between ӳý and Bayer Pharmaceuticals, <a href="/news/broad-institute-and-bayer-join-forces-develop-novel-treatment-options-cancer-therapy">which began in 2013</a>. The team's clinical success demonstrates that long-term academic-industry partnerships can close the gap between biological discoveries and new medicines that improve health.</p> <p>"The whole idea of the ӳý when it was founded more than 20 years ago was to bring the power of human genome science and high-throughput research to solving human disease," said <a href="/bios/matthew-meyerson">Matthew Meyerson</a>, a lead cancer biologist on the project, institute member at the ӳý, the Charles A. Dana Chair in Human Cancer Genetics at Dana-Farber Cancer Institute, and professor of genetics and medicine at Dana-Farber and Harvard Medical School. "Today, with our industry partners at Bayer, we're now able to see the fruits of these efforts in a new drug that we hope can help many patients by extending their lifespan and improving their quality of life."</p> <h2>New option for lung cancer patients</h2> <p>Lung cancer is the leading cause of cancer-related deaths in the US, and non-small-cell lung cancer (NSCLC) accounts for more than 85 percent of lung cancer cases. Up to 4 percent of NSCLC cases carry a <em>HER2</em> gene mutation, which causes the HER2 protein to become overactive and spur abnormal cell growth.</p> <p>Sevabertinib halts the activity of HER2 proteins with certain mutations, inhibiting the growth of tumors. Approved as a second-line treatment, it may serve a patient population that until recently had no remaining options after chemotherapy or immunotherapy for treating their cancer.</p> <p>The FDA granted sevabertinib a <a href="https://www.bayer.com/media/en-us/bayer-receives-us-fda-breakthrough-therapy-designation-for-bay-2927088-for-non-small-cell-lung-cancer-harboring-her2-activating-mutations/">Breakthrough Therapy designation</a> in 2024, signifying that the compound may provide substantial improvement over existing therapies in an area of high unmet medical need. In 2025, sevabertinib was additionally <a href="https://www.bayer.com/en/us/news-stories/sevabertinib">granted Priority Review status</a>, meaning the FDA would aim to take action on an application within six months (compared to ten months under standard review).</p> <h2>A research success story</h2> <p>This milestone began with work <a href="https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020313">first published in 2005</a> led by Meyerson and <a href="/bios/heidi-greulich">Heidi Greulich</a>, an institute scientist and senior group leader in the Cancer Program at the ӳý.</p> <p>In 2005, the ӳý team reported that some lung cancer patients who didn't respond to existing drugs had a mutation in their tumors known as an “exon 20 insertion” — an extra bit of DNA tucked in at a specific location in the gene <em>EGFR</em>. Developing a drug to target this mutation was one of the first projects for the ӳý-Bayer alliance when it launched in 2013, and the work soon evolved into creating a drug to target a similar mutation in <em>HER2</em>, a gene closely related to <em>EGFR</em> that’s involved in lung and other cancers.</p> <p>"We've been collaborating closely with the Bayer team on sevabertinib and its precursor compounds for 12 years now,” said Greulich. “It really shows how the power of persistence can be brought to bear on difficult problems to help patients."</p> <p>A Phase III clinical trial is continuing to evaluate sevabertinib as a first-line treatment option for patients with NSCLC carrying <em>HER2</em> mutations. The drug is also being studied in patients with other metastatic or unresectable solid tumors, beyond lung cancer, that have <em>HER2</em> mutations.</p> <p>"We're in an extraordinary time for the development of new medicines to treat cancer patients," said Meyerson. "And I think that, with our industry partners, we have a huge opportunity to repeat this success not once, not twice, but many, many times over."</p> </div> </div> </div> </div> </div> </div> </div> <div class="content-section container"> <div class="content-section__main"> <div class="block-node-broad-tags block block-layout-builder block-field-blocknodelong-storyfield-broad-tags"> <div class="block-node-broad-tags__row"> <div class="block-node-broad-tags__title">Tags:</div> <div class="field field--name-field-broad-tags field--type-entity-reference field--label-hidden field__items"> <div class="field__item"><a href="/broad-tags/industrial-partnerships" hreflang="en">Industrial partnerships</a></div> <div class="field__item"><a href="/broad-tags/cancer" hreflang="en">Cancer</a></div> <div class="field__item"><a href="/broad-tags/matthew-meyerson" hreflang="en">Matthew Meyerson</a></div> </div> </div> </div> </div> </div> Thu, 20 Nov 2025 10:00:00 +0000 leah@broadinstitute.org 5559726 at