Blueprint Medicines' Ayvakit (avapritinib) Receives FDA's Approval to Treat Patients with Advanced Systemic Mastocytosis
Shots:
- The full FDA approval is based on data from 2 clinical trials i.e.- P-I EXPLORER & P-II PATHFINDER trial evaluating the efficacy of Ayvakit (200 mg- PO- qd) in 53 adults with advanced SM including ASM- SM-AHN & MCL
- Results: @median follow-up of 11.6 mos.- ORR (57%)- CR/CRh (28%)- PR (28 %) & clinical improvement (15%)- m-DoR (38.3 mos.). Treatment response was evaluated using modified IWG-MRT-ECNM criteria & additional efficacy measures are DoR- resolution- >50% reductions in biomarker response- mast cell burden & serum tryptase
- Ayvakit is not recommended for patients with low platelet counts (<50-000/µL). This approval marks the 1st targeted therapy that inhibits D816V mutant KIT
| Ref: Blueprint Medicines | Image: PR Newswire
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