NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended conditional approval for Amgen's sotorasib (Lumakras in the US/Lumykras in the EU) for previously treated, advanced non-small cell lung cancer patients harboring KRAS G12C mutations.
The committee based its positive opinion on results from the Phase II CodeBreak 100 trial, in which 124 KRAS G12C-mutated NSCLC patients on sotorasib had a median overall survival of 12.5 months, a median progression-free survival of 6.8 months, and a response rate of 37 percent. All patients in the study had received prior immunotherapy or chemotherapy.
The recommendation in Europe follows accelerated approval in the US for the same patient population in May, marking the first US Food and Drug Administration approval of a KRAS-targeting drug.
If the European Commission follows CHMP's recommendation and approves sotorasib — a decision expected in mid-January 2022 — the agent would likewise be the first commercially available drug in Europe for this previously "undruggable" target.
"As we move closer to a potential EMA approval, it is critical that we continue to increase the implementation of biomarker testing so we can match the right patients who may benefit from this first-in-class targeted therapy as quickly as possible," Jurgen Wolf, medical director of the Center for Integrated Oncology at the University Hospital of Cologne, Germany, said in a statement on Friday announcing CHMP's decisions.
In approving the drug earlier this year, the FDA also approved two companion diagnostics — Qiagen's Therasceen KRAS RGQ PCR kit and Guardant Health's Guardant360 CDx liquid biopsy test — that can identify patients eligible for treatment.