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According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation.
Amgen announced on Jan. 9, 2022, that the European Commission (EC) granted conditional marketing authorization for the company’s first-in-class KRASG12C inhibitor, LUMYKRAS (sotorasib), for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients that have progressed after one prior line of systemic therapy. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended conditional authorization in November 2021.
According to an Amgen press release, the conditional authorization was based on results from a Phase II CodeBreaK 100 clinical trial in NSCLC. “LUMYKRAS 960 mg, administered orally once-daily, demonstrated an objective response rate of 37.1% (95% CI: 28.6-46.2) and a median duration of response (DoR) of 11.1 months. The most common adverse reactions were diarrhea (34%), nausea (25%), and fatigue (21%). The most common severe (grade ≥ 3) adverse reactions were increased alanine aminotransferase level (ALT; 5%), increased aspartate aminotransferase (AST; 4%), and diarrhea (4%),” Amgen stated in the press release.
"The approval of LUMYKRAS, the first and only targeted therapy for KRAS G12C-mutated NSCLC with proven efficacy, has the potential to transform treatment outcomes for people in the European Union living with this notoriously difficult-to-treat cancer," said David M. Reese, executive vice president of Research and Development at Amgen, in the press release. "Amgen's landmark scientific discovery allowed investigators to advance the first KRASG12C inhibitor into the clinic, and we look forward to bringing this critical innovation to more patients across the globe."