Amgen’s Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation

Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRAS^G12C inhibitor, sotorasib, for 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 J. Addario, cofounder and board chair of the GO2 Foundation for Lung Cancer. “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.”

KRAS G12C is the most common KRAS mutation in NSCLC.^1,2  In the U.S., about 13% of patients with NSCLC adenocarcinoma harbor the KRAS G12C mutation³ and each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated NSCLC.⁴  Unmet need remains high and options are limited for NSCLC patients with the KRAS G12C mutation that have failed first-line treatment. The outcomes with current therapies are suboptimal with response rates of approximately 9-18% and a median progression-free survival of approximately 4 months for second-line NSCLC.^5,6,7  

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research⁸ by developing sotorasib. Sotorasib was the first KRAS^G12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across 4 continents. In just over two years, the sotorasib clinical program has also established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

“Breakthrough Therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it.”

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