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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze