FDA Signs Off On Bayer's New Lung Cancer Drug — Early Results Look Promising

Core Insights - The FDA granted accelerated approval to Bayer AG's Hyrnuo (sevabertinib) for adults with advanced lung cancer characterized by HER2 tyrosine kinase domain activating mutations [1][3] - The Oncomine Dx Target Test was approved as a companion diagnostic to identify eligible patients for sevabertinib treatment [2] - Amgen Inc.'s Imdelltra received full approval for extensive stage small cell lung cancer, showing a 40% reduction in death risk and extending median overall survival by over five months compared to standard chemotherapy [5] Bayer AG and Hyrnuo - Hyrnuo's monthly list price is set at $24,000 [3] - In a study involving 70 patients, the confirmed objective response rate (ORR) was 71%, with a median duration of response (DOR) of 9.2 months; 54% of responding patients had a DOR of six months or more [3] - Among 52 patients, the ORR was 38%, with a median DOR of 7.0 months; 60% of responding patients had a DOR of six months or more [4] - The recommended dosage for sevabertinib is 20 mg orally twice daily with food until disease progression or unacceptable toxicity [4] Amgen Inc. and Imdelltra - Imdelltra received full FDA approval for patients with extensive stage small cell lung cancer who experienced disease progression after platinum-based chemotherapy [5] - The global Phase 3 DeLLphi-304 study demonstrated a 40% reduction in the risk of death and significantly extended median overall survival by more than five months compared to standard of care chemotherapy [5]