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The Food and Drug Administration (FDA) on Wednesday granted accelerated approval to Bayer AG‘s (OTC:BAYRY) Hyrnuo (sevabertinib) for adults with a specific type of advanced lung cancer.
The approval covers locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations and who have received a prior systemic therapy.
The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with sevabertinib.
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Reuters reported the monthly list price for Hyrnuo is $24,000.
In a study, 70 patients with locally advanced or metastatic NSCLC with HER2 TKD activating mutations who had received prior systemic therapy but were naive to therapy targeting HER2 mutations, the confirmed objective response rate was 71%, with a median duration of response (DOR) of 9.2 months, and 54% of responding patients had a DOR of ≥ 6 months.
Among 52 patients with locally advanced or metastatic NSCLC with HER2 TKD activating mutations who had received prior systemic therapy, ORR was 38%, with a median DOR of 7.0 months, and 60% of responding patients had a DOR of ≥ 6 months.
The recommended sevabertinib dose is 20 mg orally twice daily with food until disease progression or unacceptable toxicity.
In another update, the FDA granted full approval to Amgen Inc.’s (NASDAQ:AMGN) Imdelltra (tarlatamab-dlle) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
The global Phase 3 DeLLphi-304 study met its primary endpoint, demonstrating that Imdelltra reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy.
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