Delcath Systems’ Hepzato KIT Receives the US FDA’s Approval for Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
Shots:
- The US FDA has approved Hepzato KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with mUM with unresectable hepatic metastases. The approval was based on the results from the P-III study (FOCUS) of Hepzato KIT via the hepatic delivery system (HDS) during a PHP procedure in 91 patients
- The results showed ORR was 36.3% in patients with hepatic and extrahepatic lesions and m-DoR was 14mos., DCR was 73.6% with 7 complete responses (7.7%), and PR (28.6%)
- The product is expected to be available in Q4’23 and enrolled patients will continue treated at Expanded Access Program (EAP) sites. Hepzato Kit is supplied with the Hepzato 5×5 Drug Pack and the HDS
Ref: PR Newswire | Image: Delcath Systems
Related News:- Foghorn Therapeutics Reports Discontinuation of P-I Clinical Trial for FHD-286 in Metastatic Uveal Melanoma (mUM)
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