US-based Amgen (NASDAQ: AMGN) has announced receiving clearance from the US Food and Drug Administration (FDA) for its Lumakras (sotorasib) combined with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This approval is for patients whose cancer has been identified through an FDA-approved test and who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Combination Therapy Details
Sotorasib is a KRAS G12C inhibitor, while Vectibix is a monoclonal anti-EGFR antibody. Clinical trial results demonstrated that the combination of sotorasib and panitumumab significantly extended progression-free survival, achieved a higher objective response rate, and provided a relatively longer duration of response in patients with KRAS G12C mutant mCRC. Although there was no statistically significant difference in overall survival, the overall data suggests that this combination therapy holds potential clinical value in treating such patients.
Significance of the Approval
This FDA clearance marks a significant step forward in the treatment of KRAS G12C-mutated metastatic colorectal cancer, offering a new therapeutic option for patients who have limited treatment choices. The approval underscores Amgen’s ongoing commitment to developing innovative oncology therapies and improving patient outcomes.-Fineline Info & Tech
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