European Commission approves Lumykras for lung cancer patients

pharmafile | January 10, 2022 | News story | Sales and Marketing  

The European Commission (EC) has granted conditional marketing authorisation for Lyumykras (sotorasib), a first-in-class KRAS inhibitor, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation.

The EC decision follows the CHMP recommendation for approval, and is based on the positive results from the Phase II CodeBreaK 100 clinical trial in NSCLC, which was the largest trial ever conducted for patients with the KRAS G12C mutation.

Lumykras demonstrated an objective response rate of 37.1%, and a median duration of response (DoR) of 11.1 months.

NSCLC accounts for over 80% of the 2.2 million new lung cancer diagnoses globally each year, including approximately 400,000 new cases in Europe. KRAS G12C is one of the most common mutations in NSCLC, and about 13-15% of European patients with non-squamous NSCLC have this mutation.

This EC approval means that clinicians in EU member countries, alongside Norway, Iceland, and Liechtenstein, will be able to offer Lumykras to eligible patients with NSCLC.

“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, MD, executive vice president of Research and Development at Amgen.

“Amgen’s landmark scientific discovery allowed investigators to advance the first KRAS inhibitor into the clinic, and we look forward to bringing this critical innovation to more patients across the globe.”

Lina Adams

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