FDA Grants Accelerated Approval to Bayer's Hyrnuo for HER2-Mutated Lung Cancer

Bayer's drug Hyrnuo, whose generic name is sevabertinib, has secured accelerated approval from the US Food and Drug Administration. The clearance positions it as a first-line targeted therapy for patients with HER2-mutated non-small cell lung cancer.

The approval marks the first time a targeted treatment has been authorised for use as an initial therapy in this specific patient group. Non-small cell lung cancer is the most common form of lung cancer, and HER2 mutations represent a distinct subset of the disease that has lacked dedicated first-line targeted options.

Accelerated approval is a regulatory pathway that allows earlier market entry for therapies addressing serious conditions with unmet medical need, typically contingent on confirmatory trials. Bayer announced the development on Tuesday.

The decision expands the treatment landscape for patients whose tumours carry HER2 mutations, offering a targeted approach from the outset of care rather than reserving such options for later lines.