Shots:
- Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative options
- Approval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which established efficacy on the basis of ORR & DoR by IRC per RECIST version 1.1; 5yr. analysis was published in The JCO(2025) & full results in Journal for ImmunoTherapy of Cancer(2022)
- Amtagvi is being investigated P-III (TILVANCE-301) trial in combination with Keytruda vs Keytruda alone for advanced melanoma as well as other trials for additional solid tumor types
Ref: Iovance| Image: Iovance| Press Release
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