FDA approves Bayer's Hyrnuo as first-line therapy for HER2-mutant NSCLC
The FDA issued an accelerated approval allowing Bayer's oral tyrosine kinase inhibitor Hyrnuo as first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors harbor HER2 tyrosine kinase domain activating mutations. The decision was based on Soho-01 phase 1/2 data showing a 75% objective response rate in previously untreated patients, including 6% complete responses and 70% partial responses, with 73% of responses lasting more than six months. The approval requires post-marketing confirmatory studies and comes amid direct competition from Boehringer Ingelheim's recently approved rival, Hernexeos.
Hyrnuo gains FDA accelerated first-line approval for HER2-mutant NSCLC.
Context
Bayer tested Hyrnuo in the Soho-01 trial that showed high response rates. The FDA granted accelerated first-line approval based on those data. Bayer must complete confirmatory trials such as the phase 3 Soho-02 next.
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