RMAT designation for anzu-cel in post-PD-1 melanoma
- Sponsor
- Immatics N.V. $IMTX
- Drug
- anzu-cel
- Indication
- unresectable or metastatic melanoma after prior anti-PD-1 therapy
FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Immatics' anzu-cel, a PRAME-directed TCR-T cell therapy, for unresectable or metastatic melanoma after prior anti-PD-1 therapy. RMAT confers all benefits of Breakthrough Therapy Designation plus early-interaction pathways specific to cell and gene therapies.
What this means
Melanoma is a serious form of skin cancer, and while newer immunotherapies help many patients, most eventually stop responding. Anzu-cel is a cell therapy that reprograms a patient's own T-cells to recognise and attack melanoma cells carrying a specific tumour marker called PRAME. FDA's RMAT designation is reserved for regenerative medicines that show early evidence of addressing a serious unmet need; it opens up more frequent interactions with the FDA and includes the benefits of Breakthrough Therapy Designation. Anzu-cel is being tested in a Phase 3 trial called SUPRAME against physician's choice in patients whose melanoma has progressed after PD-1 checkpoint blockade.