FDA nod for Lumakras with Vectibix combo for mCRC

17 January 2025

The US Food and Drug Administration approved sotorasib (trade name Lumakras) with panitumumab Vectibix), from US biotech major Amgen (Nasdaq: AMGN), 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 FDA also approved the therascreen KRAS RGQ PCR Kit (from Qiagen) as a companion diagnostic device to aid in identifying patients with colorectal cancer whose tumors harbor KRAS G12C mutations and who may be eligible for Lumakras with Vectibix, the agency noted.

The FDA’s decision was supported by results from the open-label CodeBreaK 300 trial, which randomised 160 patients to receive either a 960mg or 240mg oral dose of Lumakras once daily, both taken in combination with a 6mg/kg intravenous dose of Vectibix every two weeks, or investigator’s choice of standard of care (SOC) trifluridine/tipiracil or regorafenib.

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