The US Food and Drug Administration has approved sevabertinib, an oral targeted therapy for adult patients with non-small-cell lung cancer (NSCLC) whose tumors harbor certain HER2 (also called ERBB2) mutations and who have previously received chemotherapy or immunotherapy. The approval reflects a multi-year collaboration led by Dana-Farber Cancer Institute investigators, working closely with colleagues at the Broad Institute.
"This is an important step forward for patients," said Dr. Matthew Meyerson, the Charles A. Dana Chair in Human Cancer Genetics at Dana-Farber Cancer Institute, professor of genetics and medicine at Dana-Farber and Harvard Medical School, and an institute member at the Broad Institute. "So hopefully this will prove to be of benefit for patients with ERBB2 mutant lung cancers, and perhaps for some other indications as well."
Sevabertinib is a targeted medicine designed to block abnormal HER2 signals that drive tumor growth. It also affects a related pathway, EGFR, while largely sparing the normal form of EGFR-an approach intended to help limit side effects. As a pill that can be taken at home, it offers a new option for a patient population with few effective treatments-estimated at roughly 4,000 to 8,000 people in the United States each year, many of whom are women, including younger women who have never smoked.
The FDA's decision is supported by clinical studies showing that sevabertinib can shrink tumors and keep disease under control. In these studies, more than half of patients saw their tumors shrink, and in one study group the response rate was over 70 percent; about 80 percent had their disease stabilized or reduced. Sevabertinib previously received Breakthrough Therapy designation in 2024 and was granted Priority Review in 2025. A large, ongoing clinical trial is now testing sevabertinib as a first treatment for patients with HER2-mutant NSCLC, and researchers are also studying the medicine in other solid tumors with HER2 mutations.
The approval builds on discoveries made nearly two decades ago at Dana-Farber and the Broad. In 2005, research led by Meyerson and collaborators identified a specific genetic change in the EGFR gene-an "exon 20 insertion"-that helped explain why some lung cancers resist available treatments. That insight paved the way for designing medicines that precisely target similar activating mutations in HER2. Researchers in Meyerson's lab, together with senior colleagues at the Broad, then advanced sevabertinib to target these HER2 mutations.
"I continue to be very grateful for the remarkable research environment here at Dana-Farber with amazing colleagues and trainees, our emphasis on the full continuum of basic and translational and clinical cancer research, and also our openness to collaboration with the Broad across the decades that has made this research possible," Meyerson added.
