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Amgen (AMGN) Submits NDA for KRAS Inhibitor for Lung Cancer

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Amgen, Inc. (AMGN - Free Report) submitted a new drug application seeking approval of its investigational KRAS inhibitor, sotorasib for the treatment of locally advanced/metastatic non-small-cell lung cancer (“NSCLC”) in patients with KRAS G12C mutation.

The NDA filing was based on positive data from the phase II CodeBreaK 100 study, which evaluated sotorasib in patients with advanced NSCLC whose disease progressed despite prior treatment with chemotherapy and/or immunotherapy. Data from the study showed that treatment with sotorasib led to deep and durable anticancer activity with a positive benefit-risk profile in the given patient population.

The sotorasib application is being reviewed under the FDA's Real-Time Oncology Review Pilot Program, which ensures a more efficient review process to provide safe and effective treatments to patients as early as possible.

Notably, tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy.

Per the company, KRAS G12C mutations are present in approximately 13% of NSCLC adenocarcinomas. There is a high unmet medical need for the given indication as NSCLC patients with KRAS G12C mutation who have failed first-line treatment have limited treatment options available. Following its successful development and potential approval, sotorasib can serve a market with significantly unmet need.

Amgen’s stock has declined 5.2% this year so far against an increase of 9.2% for the industry.

 

 

Sotorasib is also being evaluated in a phase II monotherapy study in advanced colorectal cancer patients whose top-line data are expected to be released next year. Amgen is also conducting phase Ib combination studies on sotorasib with PD-1, MEK and other targeted therapies.

We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Apart from Amgen, Eli Lilly (LLY - Free Report) and J&J (JNJ - Free Report) have KRAS G12C inhibitor candidates in their pipelines. Small biotech, Mirati Therapeutics (MRTX - Free Report) also has adagrasib, a KRAS G12C inhibitor, in its pipeline.

Amgen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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