Currently Enrolling Trials
Gavreto (pralsetinib) is a kinase inhibitor.
Gavreto is specifically indicated for adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer as detected by an FDA approved test.
Gavreto is supplied as a capsule for oral administration. The recommended dose is 400 mg orally once daily on an empty stomach. No food should be taken for at least 2 hours before and at least 1 hour after taking Gavreto.
Gavreto was approved under the FDA's accelerated approval program, based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial.
The FDA approval of Gavreto was based on ARROW, a multicenter, non-randomized, open-label, multi-cohort phase 1/2 trial. The study enrolled, in separate cohorts, patients with metastatic RET fusion positive NSCLC who had progressed on platinum-based chemotherapy and treatment-naïve patients with metastatic NSCLC. Patients received Gavreto 400mg orally once daily until disease progression or unacceptable toxicity. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as assessed by a blinded independent central review (BICR) according to RECIST v1.1. Efficacy was evaluated in 87 patients with RET fusion-positive NSCLC with measurable disease who were previously treated with platinum chemotherapy enrolled into a cohort of ARROW. Gavreto demonstrated an overall response rate (ORR) of 57% and complete response (CR) rate of 5.7% in the 87 people with NSCLC previously treated with platinum-based chemotherapy, and the median duration of response (DoR) was not reached. In the 27 people with treatment-naïve NSCLC, the ORR was 70%, with an 11% CR rate.
Adverse effects associated with the use of Gavreto may include, but are not limited to, the following:
- musculoskeletal pain
Mechanism of Action
Gavreto (pralsetinib) is a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations.
For additional information regarding Gavreto or RET fusion- positive non-small cell lung cancer, please visit the Gavreto website.