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Breaking news on Precision Oncology business, policy & funding.
In Europe, Blueprint will commercialize the drug first in Germany as a treatment for advanced GIST patients with a PDGFRA D842V mutation.
The company will seek FDA approval in advanced systemic mastocytosis, a disorder that can turn into cancer in 7 percent of children and 30 percent of adults.
Avapritinib is sold by Blueprint Medicines as Ayvakit for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation.
The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.
The company will use the proceeds to advance its lead BRAF inhibitor, PLX-8394, and develop new precision drugs using its FACT platform.