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# Amgen’s Lumakras/Vectibix OK’d in Colon Cancer
- URL: https://www.fdaweb.com/amgens-lumakras-vectibix-okd-in-colon-cancer/
- Published: 2025-01-17T12:00:00.000Z
- Updated: 2026-09-14T14:51:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158507

FDA has approved Amgen’s Lumakras (sotorasib) for use with its Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The agency also approved Qiagen’s therascreen KRAS RGQ PCR Kit as a companion diagnostic to aid in identifying patients with colorectal cancer whose tumors harbor KRAS G12C mutations and who may be eligible for the treatment.

The combination therapy was approved based on data from CodeBreaK 300 (NCT05198934), a randomized trial involving 160 patients. Data show that median progression-free survival (PFS) was 5.6 months in the sotorasib 960mg/panitumumab arm and 2 months in the standard-of-care (SOC) arm, an [FDA release](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sotorasib-panitumumab-kras-g12c-mutated-colorectal-cancer&ved=2ahUKEwictvGZof2KAxWhv4kEHW0qPCoQvOMEKAB6BAgREAE&usg=AOvVaw0OXNpKCESzf5TC3opmyEwY) says. The objective response rate was 26% in the combination therapy arm and 0 in the SOC arm. “The final analysis of PFS for patients randomized to the sotorasib 240 mg/panitumumab arm compared to the SOC arm was not statistically significant,” it says.

Regarding safety, the most common adverse reactions (greater than 20%) for sotorasib 960 mg/panitumumab were rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain, FDA says. The most common Grade 3-4 laboratory abnormalities were decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium.