Seagen Receive the US FDA’s Accelerated Approval of Tukysa (tucatinib) for RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
Shots:
- The US FDA has granted accelerated approval to Tukysa (tyrosine kinase inhibitor) + trastuzumab for RAS wild-type, HER2+ unresectable or metastatic colorectal cancer
- The approval was based on the P-II study (MOUNTAINEER) evaluating Tukysa (300mg, BID) + trastuzumab (8mg/kg loading dose, IV & 6mg/kg, q3w) in 84 patients, showed ORR (38%), CR (3.6%) & PR (35%), m-DoR (12.4mos.), 64% & 70% had liver or lung metastases, permanent treatment discontinuation due to AEs (6%)
- The therapy was approved in the US in combination with trastuzumab & capecitabine for HER2+ breast cancer. Merck commercializes Tukysa outside of the US, Canada & EU and will discuss (MOUNTAINEER) trial results with health authorities to accelerate Tukysa’s filing in its territories
Ref: Bussinesswire | Image: Seagen
Related News:- Seagen Receive the US FDA’s Accelerated Approval of Tukysa (tucatinib) for RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
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