Leverkusen-based pharmaceutical company Bayer has received approval for a new lung cancer drug from the US Food and Drug Administration (FDA). The drug, under the brand name Hyrnuo, has been approved for patients with non-small cell lung cancer (NSCLC) who have mutations in the HER2 protein and whose disease continues to progress despite previous treatment, the FDA said. Oral drugs belong to the class of kinase inhibitors, which inhibit the growth of cancer cells. The monthly list price for Hyrnuo is $24,000.
The approval was based on a study involving a total of 70 patients who received Hyrnuo after previous cancer treatment. The drug worked in 71 percent of patients – the tumors shrank or disappeared. In a subgroup of 52 patients who had received HER2-targeted therapy, the treatment was successful in 38 percent. This approval is a welcome addition to the treatment spectrum, explained Bayer manager Chandrasekhar Goda. The FDA also approved a diagnostic test from Life Technologies Corporation that can determine which patients have the necessary HER2 mutations.
With this approval, competition in the NSCLC drug market is getting tougher. In addition to Boehringer Ingelheim’s Hernexeos, which was approved in August to treat a type of lung cancer, Hyrnuo also competes with AbbVie’s Emrelis as well as established therapies Merck’s Keytruda and AstraZeneca’s Tagrisso. NSCLC is the most common form of lung cancer, accounting for 80 to 85 percent of all cases.
