The FDA delivered a double dose of good news for lung cancer patients this week, greenlighting treatments from two pharmaceutical heavyweights that target different forms of the disease.
On Wednesday, Bayer AG (BAYRY) earned accelerated approval for Hyrnuo (sevabertinib), a targeted therapy for adults battling a specific strain of advanced lung cancer. The drug addresses locally advanced or metastatic, non-squamous non-small cell lung cancer in patients whose tumors harbor HER2 tyrosine kinase domain activating mutations and who've already cycled through at least one prior systemic therapy.
This isn't a mass-market blockbuster. The FDA approval is remarkably specific, requiring a companion diagnostic test to identify eligible patients. The agency simultaneously approved the Oncomine Dx Target Test from Life Technologies Corporation to detect HER2 (ERBB2) TKD activating mutations in non-squamous NSCLC patients who might benefit from sevabertinib treatment.
According to Reuters, Hyrnuo commands a monthly list price of $24,000, which puts it squarely in the premium tier of cancer therapeutics.
The Clinical Evidence
The approval hinged on compelling trial data. Among 70 patients with locally advanced or metastatic NSCLC carrying HER2 TKD activating mutations who had received prior systemic therapy but were naive to HER2-targeted treatments, the confirmed objective response rate hit 71%. The median duration of response clocked in at 9.2 months, with 54% of responding patients maintaining their response for at least six months.
A separate cohort of 52 patients with the same mutation profile who had received prior systemic therapy showed a 38% objective response rate. Their median duration of response was 7.0 months, with 60% of responders hitting the six-month mark or beyond.
The recommended dosing is straightforward: 20 mg orally twice daily with food until disease progression or intolerable side effects emerge.
Amgen's Bigger Victory
Meanwhile, Amgen Inc. (AMGN) notched a full FDA approval for Imdelltra (tarlatamab-dlle), which treats extensive stage small cell lung cancer after platinum-based chemotherapy has failed. This marks an upgrade from its previous accelerated approval status.
The global Phase 3 DeLLphi-304 study delivered impressive results, hitting its primary endpoint by showing Imdelltra reduced the risk of death by 40% compared to standard chemotherapy. Patients on Imdelltra lived more than five months longer on average than those receiving conventional treatment—a meaningful extension for a patient population with notoriously poor prognosis.
Both approvals underscore how targeted therapies continue reshaping the lung cancer treatment landscape, particularly for patients who've run out of conventional options. For Bayer and Amgen, these wins represent validation of years of research into molecular subtypes of lung cancer that were once considered essentially untreatable.
