FDA Grants Priority Review to Sotorasib to Treat Patients With KRAS G12C–Mutated NSCLC

Amgen announced that their new drug application for sotorasib was granted priority review by the FDA to treat patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.

The FDA granted priority review to sotorasib to treat patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer (NSCLC), according to an Amgen press release.

The designation for sotorasib is intended for patients with this disease following at least 1 prior systemic therapy. The drug has a Prescription Drug User Fee Action (PDUFA) date of August 16, 2021, which is 4 months earlier than the FDA’s typical review cycle.

The new drug application (NDA) comes in response to data from the CodeBreaK 100 clinical trial (NCT03600883) that was presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC).

Amgen submitted the NDA for sotorasib on December 16, 2020, and the FDA is reviewing the application via Real-Time Oncology Review (RTOR), which is a pilot program that “aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.”

The phase 2, first-in-human, open-label, multicenter study is investigating sotorasib in patients with this type of NSCLC whose cancer progressed despite previous treatment with chemotherapy and/or immunotherapy. So far, the trial has recruited a total of 126 patients, including 124 who had centrally evaluable lesions by RECIST at baseline.

The primary end point of the data examined centrally assessed objective response rate.

On the heels of these data, the global, randomized, active-controlled phase 3 CodeBreaK 200 study (NCT04303780) is currently recruiting patients with previously treated KRAS G12C–mutant NSCLC. The trial will investigate sotorasib compared with docetaxel as treatment for their disease.

Sotorasib was previously granted breakthrough therapy designation in China and the United States. More, Amgen submitted Marketing Authorization Applications (MAAs) for sotorasib in the European Union in December 2020, as well as in Australia, Brazil, Canada, and the United Kingdom in January 2021 for participation in the FDA’s Project Orbis initiative.

The KRAS G12Cinhibitor sotorasib has a clinical program within Amgen producing a thorough clinical data set with more than 700 patients studied across 13 tumor types in over 2 years’ time.


FDA grants sotorasib priority review designation for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. News release. Amgen. Published February 16, 2021. Accessed February 16, 2021. https://www.prnewswire.com/news-releases/fda-grants-sotorasib-priority-review-designation-for-the-treatment-of-patients-with-kras-g12c-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancer-301229256.html.