FDA Approves Amgen Treatment For Pretreated Colorectal Cancer With Certain Mutation

The Food and Drug Administration approved Amgen Inc‘s AMGN Lumakras (sotorasib) in combination with Vectibix (panitumumab) for KRAS G12C-mutated metastatic colorectal cancer (mCRC), who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. 

Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that Lumakras plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC).

Also Read: Amgen Reveals Data From Closely Watched Monthly Obesity Drug, With Weight Loss Of Up To 20% At One Year And No Plateau

The CodeBreaK 300 results demonstrated that Lumakras 960 mg daily plus Vectibix (n=53) showed an improved median progression-free survival (PFS) of 5.6 months compared to 2 months on the investigator’s choice of care (n=54).

The study demonstrated an improved overall response rate (ORR) of 26% compared to 0% with investigator’s choice.

The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with LUMAKRAS plus Vectibix was not reached, and mOS for patients treated with the investigator’s choice was 10.3 months, with an HR of 0.7; the final analysis of OS was not statistically significant. 

The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers.

Price Action: Amgen stock is up 0.99% at $272.11 at last check Friday.

Read Next:

• ServiceNow Expands AI Arsenal With Cuein Acquisition: Details

Image: Shutterstock