Amgen Submits New Drug Application for Sotorasib to Treat KRAS G12C-Mutated Non-Small Cell Lung Cancer

On December 16, Amgen announced that it had submitted a New Drug Application (NDA) to the U.S. FDA for its investigational KRAS G12C inhibitor sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have previously received at least one prior systemic therapy. The FDA will review the NDA under the Real-Time Oncology Review (RTOR) pilot program, which aims to explore more efficient review processes to ensure timely access to safe and effective treatments for patients.

KRAS G12C is the most common KRAS mutation in NSCLC. In the United States, approximately 13% of NSCLC patients harbor the KRAS G12C mutation. There is a high unmet need and poor prognosis for second-line treatment in patients with KRAS G12C-driven NSCLC, and currently, no targeted therapies for KRAS G12C have been approved.

Sotorasib, developed by Amgen, is a once-daily oral KRAS G12C inhibitor. It is currently being investigated in an extensive clinical program exploring the efficacy of 10 combination therapies. In just over two years, the sotorasib clinical program has treated more than 600 patients across 13 tumor types.

This application is supported by positive Phase 2 clinical trial results in patients with locally advanced or metastatic NSCLC. Enrolled patients experienced disease progression despite prior treatment with chemotherapy and/or immunotherapy. In this study, sotorasib demonstrated durable anticancer activity, with benefits outweighing risks. These results were presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) in January 2021.

Clinical trial data published in The New England Journal of Medicine this September showed that in patients with NSCLC, sotorasib achieved an objective response rate (ORR) of 32.2% and a disease control rate (DCR) of 88.1%, with a median progression-free survival of 6.3 months.

References:

[1] Amgen Submits Sotorasib New Drug Application To U.S. FDA For Advanced Or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation. Retrieved 2020-12-16, from https://www.prnewswire.com/news-releases/amgen-submits-sotorasib-new-drug-application-to-us-fda-for-advanced-or-metastatic-non-small-cell-lung-cancer-with-kras-g12c-mutation-301194511.html

Source: Jike Yaowen

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