Amgen KRAS drug gets FDA priority review, teeing up August approval decision

The FDA has accepted Amgen’s KRAS G12C inhibitor sotorasib for priority review. Amgen is set to learn whether the FDA will approve the landmark drug in non-small cell lung cancer (NSCLC) by the middle of August.

If approved, sotorasib will provide a new treatment option to patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. KRAS G12C is the most frequent individual KRAS mutation in NSCLC. With 14% of NSCLC patients having the mutation, there are around 14,000 new cases in the U.S. each year.

Physicians use chemotherapy and immunotherapy to treat NSCLC patients, but outcomes are poor in patients who progress despite treatment with those existing options. Amgen showed sotorasib may address that unmet need when it presented phase 2 data on the drug early this year. Investigators saw responses in 37% of patients. Median progression-free survival was 6.8 months.

Amgen used the data to file for FDA approval late last year. The FDA is assessing sotorasib through its real-time oncology review (RTOR) pilot program. Other drugs assessed under RTOR have received approval decisions ahead of schedule. 

A paper published last month found 18 of the first 20 drugs approved after a RTOR were authorized before the PDUFA date. The median approval date was 2.9 months ahead of the PDUFA target. None of the drugs required an advisory committee meeting.

Amgen is also working to make sotorasib available in other markets. The company sought approval in the EU late last year before using the FDA's Project Orbis initiative to file applications in Australia, Brazil, Canada and the U.K. early this year. 

The submissions position Amgen to become the first company to sell a drug against KRAS, a target once thought to be undruggable. Mirati Therapeutics is positioned to be the next company to bring a KRAS drug to market. In the longer term, market success may depend on which molecules impress in combinations that unlock the first-line treatment space.