The nod brings Bayer face-to-face in the market with Boehringer Ingelheim and AstraZeneca, each of which has its own HER2 blocker for non-small cell lung cancer.
The FDA gave the go-ahead Wednesday to Bayer’s oral cancer drug sevabertinib for the treatment of certain patients with non-small cell lung cancer. Sevabertinib will carry the brand name Hyrnuo.
Taken as 20-mg pills twice daily with food, Hyrnuo is indicated for patients with non-squamous non-small cell lung cancer whose tumors are positive for mutations with HER2 tyrosine kinase domain (TKD)-activating mutations, as determined by an FDA-approved test. Only patients who have undergone at least one prior line of therapy are eligible for Hyrnuo treatment.
With Hyrnuo’s approval, Bayer will go toe-to-toe with Boehringer Ingelheim, which in August won the regulator’s nod for Hernexeos, also an orally available kinase blocker approved for the same indication. Both Hernexeos and Hyrnuo were cleared under the FDA’s accelerated pathway.
For Hyrnuo, Wednesday’s approval was supported by data from Phase I/II SOHO study. Results presented last month at the 2025 meeting of the European Society for Medical Oncology showed that treatment with the drug elicited a 64% overall response rate (ORR) in patients who had prior exposure to systemic therapy but not with therapies that specifically targeted HER2. This subgroup had a median progression-free survival (PFS) of 8.3 months on Hyrnuo.
Bayer’s drug appeared to be more effective in treatment-naïve patients, inducing an ORR of 71%, with median PFS not reached. In contrast, those who had previously received HER2-directed antibody-drug conjugates saw an ORR or 38% and median PFS of 5.5 months.
Hyrnuo’s label includes safety precautions for diarrhea, liver toxicity, ocular toxicity and elevations in pancreatic enzymes, according to the FDA’s announcement.
The drug earned a bevy of FDA labels, securing breakthrough designation and orphan drug designation, and going through priority review. Hyrnuo was also evaluated under a special program at the FDA’s Oncology Center of Excellence called Project Orbis. That program allows for “concurrent submission and review of oncology drugs among international partners,” which include the health ministries in Canada, Israel and the U.K.
