Set-back for Blueprint Medicines as CRL issued for avapritinib

The US Food and Drug Administration has issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST).

The CRL states that the FDA cannot approve the application, says the drug’s developer, Blueprint Medicines (Nasdaq: BPMC), whose shares were down 2.85% at $62.45 pre-market, but had virtually recovered by late morning.

As previously announced, Blueprint Medicines, rare and cancer diseases specialist, plans to continue to commercialize Ayvakit (avapritinib) in the USA for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, and seek marketing approval for avapritinib for the treatment of this patient population in additional geographies, including the European Union.