Zongertinib

iStock, SiyueSteuber 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.

Bayer's Hyrnuo won an accelerated approval based on its tumor response showing in a phase 1/2 study. Just a few months after Boehringer Ingelheim broke into the oncology space with the first drug that can target a rare tumor type in patients with non-small cell lung cancer (NSCLC), the FDA has given its stamp of approval to a competitor in Bayer’s Hyrnuo (sevabertinib).Hyrnuo, a tyrosine kinase inhibitor (TKI), is specifically indicated for patients who have previously received treatment for nonsquamous NSCLC and whose tumors are confirmed to have relatively rare HER2 activating mutations in the tyrosine kinase domain (TKD).The twice-daily oral med was cleared through the FDA’s accelerated approval pathway, meaning it still needs to prove its worth in a confirmatory study. Nonetheless, the FDA saw preliminary evidence of clinical benefit in Bayer’s phase 1/2 Soho-01 trial.Among 70 patients in the open-label study who had received prior systemic therapy but not therapy that specifically targets HER2 mutations, the objective response rate was 71%, according to the FDA. In that group, responses lasted a median 9.2 months, and more than half (54%) of patients experienced a duration of response lasting at least six months.As for the 52 patients in the study who had received prior HER2-targeting antibody-drug conjugates, the objective response rate was 38%. The median duration of response was seven months in that cohort, and 60% of patients maintained a response for at least six months, according to the agency.Bayer estimates that up to 84,000 people are diagnosed with NSCLC that harbors a HER2 mutation each year, the company’s head of R&D, Christian Rommel, Ph.D., said in media statement. Hyrnuo’s accelerated approval "reflects the significant potential of this therapy to advance the treatment paradigm for patients living with HER2-mutated advanced NSCLC in the U.S.," Bayer's U.S. brand lead of precision oncology Chandrasekhar Goda added in a statement.The treatment space in question is currently populated by Boehringer Ingelheim and its TKI Hernexeos, which beat Bayer and Hyrnuo to the chase with a similar FDA nod in August. Although both drugs target the same mutated tumors, Bayer’s med is specifically designated for locally advanced or metastatic nonsquamous NSCLC, while Boehringer’s label holds a small distinction for unresectable or metastatic cancer. In Boehringer’s Lung-1 phase 1b trial, Hernexeos was associated with an objective response rate of 75% among 71 patients who had received prior platinum-based chemotherapy but not a HER2-targeted TKI or ADC, with 58% of patients having a response that lasted for at least six months.With Bayer hot on Boehringer’s tail, both companies are chasing an expanded patient pool in the first-line treatment setting. Each company presented positive data for their respective offerings last month at the European Society of Medical Oncology congress, revealing largely similar outcomes, with Boehringer reporting a 77% objective response rate from its study of treatment-naïve patients and Bayer reading out a result of 71% in the same population.Boehringer, however, has already picked up an FDA breakthrough therapy designation for Hernexeos in the first-line setting.