Amgen's sotorasib gains FDA 'Breakthrough' status for NSCLC patients with KRAS G12C mutation

The US Food and Drug Administration granted a coveted Breakthrough Therapy designation for US biotech giant Amgen’s (Nasdaq: AMGN) investigational KRASG12C inhibitor, sotorasib (AMG 510).

The designation if for the use of sotorasib in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.

"For more than 40 years, scientists have been trying to target KRAS. Today's news is a welcome update for the many non-small cell lung cancer patients with the KRAS G12C mutation, who currently have no targeted therapies," said Bonnie Addario, co-founder and board chairperson of the GO2 Foundation for Lung Cancer, adding: "We are pleased that the FDA and Amgen recognize the unmet need for these patients and are working to make new treatment options available as quickly as possible."