FDA Approval Insights: Avapritinib in Indolent Systemic Mastocytosis

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Jason Gotlib, MD, who joined us to discuss the FDA approval of avapritinib (Ayvakit) in patients with indolent systemic mastocytosis. Dr Gotlib is a professor of medicine (hematology) at Stanford University and a member of Stanford Cancer Institute, both in California.

On May 22, 2023, the FDA granted approval to avapritinib for adult patients with indolent systemic mastocytosis. This approval was backed by findings from the phase 2 PIONEER trial (NCT03731260), in which avapritinib plus best supportive care (BSC) led to a total symptom score decrease of 15.6 points (95% CI, –18.6 to –12.6) vs a decrease of 9.2 points (95% CI, –13.2 to –5.2) with placebo plus BSC from baseline to week 24 (P <.003).

In our exclusive interview, Dr Gotlib discussed the significance of this approval, key efficacy and safety findings from the PIONEER trial, and the quality of life benefits that avapritinib provides for patients with indolent systemic mastocytosis.

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