FDA Delays Decision on Amgen’s Lumakras and Vectibix Combination for Metastatic Colorectal Cancer

Decision Delayed:
The FDA has delayed its decision on the supplemental new drug application (sNDA) for the combination of sotorasib (Lumakras) and panitumumab (Vectibix) for the treatment of metastatic colorectal cancer (mCRC) with the KRAS G12C mutation.

New Target Date:
The new target action date for the FDA's decision is January 17, 2025, allowing additional time to review supplemental information recently submitted by Amgen.

Clinical Data:
The sNDA is supported by data from the Phase 3 CodeBreaK 300 study, which demonstrated statistically significant superiority in progression-free survival (PFS) for both doses of sotorasib (960 mg and 240 mg) in combination with panitumumab compared to investigator's choice of therapy.

Efficacy Findings:
The median PFS for patients treated with the 960 mg dose of sotorasib plus panitumumab was 5.6 months, and for the 240 mg dose, it was 3.9 months, compared to 2.2 months for patients treated with investigator's choice.

Background:
Sotorasib received accelerated approval from the FDA in May 2021 for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation.

Ongoing Research:
Amgen is progressing with the largest and broadest global KRAS G12C inhibitor development program, exploring multiple combination regimens across various solid tumors.