publication date: Sep. 11, 2020

Drugs & Targets

Pralsetinib receives FDA approval for lung cancer with RET gene fusions

Gavreto (pralsetinib) has received an accelerated approval from FDA for adult patients with metastatic RET fusion-positive non-small cell lung cancer, as detected by an FDA-approved test.

The Oncomine Dx Target Test has also received FDA approval as a companion diagnostic for pralsetinib.

Gavreto is sponsored by Genentech, a member of the Roche Group, and Blueprint Medicines. The Oncomine Dx Target Test is sponsored by Thermo Fisher Scientific.

RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and medullary thyroid cancer, and treatment options that selectively target these genetic alterations are limited. In NSCLC, RET fusions represent approximately 1-2% of patients. Biomarker testing for these fusions is the most effective way to identify people who are eligible for treatment with Gavreto.

Efficacy was investigated in a multicenter, open-label, multi-cohort clinical trial (ARROW, NCT03037385) in patients whose tumors had RET alterations. Identification of RET gene alterations was prospectively determined in local laboratories using either next generation sequencing, fluorescence in situ hybridization, or other tests. The main efficacy outcome measures were overall response rate and response duration determined by a blinded independent review committee using RECIST 1.1.

Efficacy for RET fusion-positive NSCLC was evaluated in 87 patients previously treated with platinum chemotherapy.

The ORR was 57% (95% CI: 46%, 68%); 80% of responding patients had responses lasting 6 months or longer. Efficacy was also evaluated in 27 patients who never received systemic treatment. The ORR for these patients was 70% (95% CI: 50%, 86%); 58% of responding patients had responses lasting six months or longer.

The FDA has … Continue reading Pralsetinib receives FDA approval for lung cancer with RET gene fusions

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