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Blueprint Medicines

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.

Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.

The agency approved the drug for metastatic, RET fusion-positive, non-small cell lung cancer patients who are identified by an FDA-approved test.

The European Commission will review CHMP's recommendation and issue a decision on marketing authorization for the drug by the end of September.

The collaboration will allow the companies to expand pralsetinib to multiple cancer indications and explore codevelopment of a next-generation RET inhibitor.

The Cambridge, Massachusetts-based company recently reported positive interim results for the RET-targeting agent from the Phase I/II ARROW study.

At ASCO, Blueprint presented positive data on its RET inhibitor pralsetinib across a range of cancers and in a call with investors discussed regulatory plans in lung and thyroid cancers.  

The company filed for approval of the therapy in patients with advanced, PDGFRA exon 18-mutated gastrointestinal stromal tumors.