Dr. Zalcberg on the Approval of Avapritinib in GIST

John Zalcberg, ​PhD, OAM, the Prof & Tony Charlton Chair of Oncology​, head, Cancer Research Program, NHMRC (MRFF) Practitioner Fellow, the School of Public Health and Preventive Medicine, Monash University, discusses the approval of avapritinib (Ayvak​it) in gastrointestinal stromal tumor (GIST).

On January 9, 2020, the FDA approved avapritinib for ​the treatment of adult ​patients with unresectable or metastatic GIST who harbor a PDGFRα exon 18 mutation, including PDGFRα D842V mutations.

​Findings from the phase 1 NAVIGATOR trial, which led to the regulatory decision, demonstrated a high overall response rate of 84% in patients who received avapritinib and harbored a PDGFRα exon-18 mutation.

Additionally, the ORR was 89% in the population of patients with PDGFRα D842V mutations, which included an 8% complete response rate and an 82% partial response rate.

Avapritinib now has a ​significant role in the management of patients with unresectable or metastatic GIST​, Zalcberg concludes.