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# FDA Rejects Blueprint Medicines NDA for Avapritinib
- URL: https://www.fdaweb.com/fda-rejects-blueprint-medicines-nda-for-avapritinib/
- Published: 2020-05-15T12:00:00.000Z
- Updated: 2026-09-14T16:15:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146804

FDA has issued Blueprint Medicines a complete response letter for its NDA for avapritinib, indicated for treating adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). The company did not disclose FDA’s reasons for the letter or whether is requested any additional data or clinical trials. Avapritinib is a kinase inhibitor approved by FDA under the trade name Ayvakit for treating adults with unresectable or metastatic GIST who harbor a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. The company says it is continuing to advance development of avapritinib for treating systemic mastocytosis. Based on top-line results reported in April for Blueprint’s Phase 3 VOYAGER trial, the company previously announced plans to discontinue further development of avapritinib in GIST indications other than PDGFRA exon 18 mutant GIST.