Cancer drugs firm Blueprint Medicines has gained a second US approval, with its Gavreto (pralsetinib) daily pill that targets non-small cell lung cancer with RET fusion mutations.
Blueprint, which specialises in drugs that target certain mutations, will co-market the drug with Roche’s Genentech unit in the US following FDA approval based on results from the phase 1/2 ARROW clinical trial.
Approval sets up a rivalry with Eli Lilly’s RET inhibitor Retevmo (selpercatinib), and the verdict from experts at this year’s American Society of Clinical Oncology (ASCO) was that the two drugs are interchangeable, based on available trial data.
Blueprint, which made its market debut with stomach cancer drug Ayvakit in January, unveiled the data from ARROW at this year’s ASCO conference in May, shortly after Retevmo was approved by the FDA.
ARROW showed efficacy for Gavreto in patients with RET fusion-positive NSCLC with or without prior therapy and regardless of RET fusion partner or central nervous system involvement.
The drug is designed to selectively and potently inhibit RET alterations that drive many cancer types, including around 1-2% of patients with NSCLC.
Blueprint and Roche are co-developing Gavreto globally, excluding Greater China, for patients with RET-altered NSCLC and various types of thyroid cancer and other solid tumours.
The FDA accepted a filing for Gavreto in RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive NSCLC. It has been granted FDA Breakthrough Therapy for RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC requiring systemic treatment and for which there are no acceptable alternative treatments.
Recruitment is ongoing in the phase 1/2 ARROW trial, including for patients with various RET fusion-positive solid tumours, and the phase 3 AcceleRET lung trial for treatment-naïve patients with RET fusion-positive NSCLC.
Gavreto is a once-daily oral targeted therapy approved by the FDA for the treatment of adults with metastatic RET fusion-positive NSCLC as detected by an FDA approved test.
It is designed to selectively and potently target oncogenic RET alterations. In pre-clinical studies, GAVRETO inhibited RET at lower concentrations than other pharmacologically relevant kinases, including VEGFR2, FGFR2 and JAK2.