Supplemental NDA for Lumakras accepted by FDA for full approval to treat previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer.-Amgen.
The supplemental New Drug Application (NDA) for full approval of Lumakras from Amgen, for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) was accepted by the FDA for standard review, and a Prescription Drug User Fee Act (PDUFA) target action date of December 24, 2023 has been set.
In June, the Company presented data demonstrating that: i.Lumakras delayed time to central nervous system (CNS) progression, had a longer CNS PFS, and a higher intracranial ORR vs docetaxel in a post-hoc analysis of the Phase III CodeBreaK 200 study in advanced NSCLC. ii. Lumakras improved PFS vs docetaxel across key co-alteration subgroups in the Phase III CodeBreaK 200 study in advanced NSCLC.
In June, data from SCARLET, a Phase II investigator study sponsored by the West Japan Oncology Group and supported by Amgen, were presented demonstrating that Lumakras, in combination with chemotherapy, demonstrated an ORR of 89%, as assessed by blinded independent central review, and favorable tolerability in first-line advanced, NSCLC patients with KRAS G12C mutation.
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