Challenge Novartis Rydapt!

CompilationFan Dongdong

A few days ago, Blueprint announced that the FDA has approved Ayvakit (avapritinib) for new indications

After being approved by the FDA, Ayvakit has become a precision therapy that specifically targets the main driving factors of the disease.

The FDA's approval decision is based on data from the Phase I EXPLORER study and the Phase II PATHFINDER study, which evaluated Ayvakit's treatment of advanced SM

In January 2020, the FDA approved the targeted anti-cancer drug Ayvakit for the treatment of unresectable or metastatic gastrointestinal tracts with mutations in exon 18 of the platelet-derived growth factor receptor alpha (PDGFRA) gene (including the PDGFRA D842V mutation) Adult patients with stromal tumor (GIST)

In February 2021, the FDA accepted the Blueprint Supplemental New Drug Application (sNDA), which seeks FDA approval of Ayvakit for the treatment of advanced SM

Previously, Ayvakit was overshadowed by the failure of the trial in the GIST population, but this time it was approved for the treatment of SM, which brought greater development opportunities to Blueprint

But SVB Leerink analyst Andrew Berens said in a report in April that according to the latest analysis of updated data from the Pathfinder trial by the American Association for Cancer Research, the drug's future competition with Rydapt may not be smooth sailing

Data released by Blueprint showed that 92% of patients with therapeutic response had to reduce the dose of Ayvakit from 200 mg at the beginning of the trial to 100 mg or even lower due to side effects

However, Berens believes that dose switching may make the drug lose its advantage over Cogent's bezuclastinib (CGT9486).

In the first quarter, Ayvakit's sales were only 7 million U.

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