Blueprint Medicines (BPMC -8.5%) is down in early trade in reaction to the FDA’s decision to split its avapritinib marketing application into two separate NDAs, one for adults with PDGFRA Exon 18 mutant gastrointestinal stromal tumor (GIST) regardless of prior treatment and the other for fourth-line GIST.
The agency wants to include topline data from the Phase 3 VOYAGER study in third- and fourth-line GIST patients but the data will not be available until Q2 2020 so an extension of the review period is likely for this indication. The current action action of February 14, 2020 will apply to the first indication.
The company plans to file a supplemental marketing application in H2 2020 for third-line GIST.
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