On August 9, 2023, the U.S. Food and Drug Administration (FDA) granted regular approval to pravlatinib (Gavreto, Genentech) for the treatment of adult patients with metastatic transfection rearrangement (RET) fusion-positive non-small cell lung cancer (NSCLC) using an FDA-approved assay.
Previously, based on initial overall response rate (ORR) and duration of response (DOR) data from the ARROW trial (NCT03037385) in 114 enrolled patients, pravlatinib received accelerated approval for this NSCLC indication on September 4, 2020. This conversion to regular approval is based on data from an additional 123 patients and results from an additional 25 months of follow-up to assess the durability of response.
Efficacy was demonstrated in a total of 237 patients with locally advanced or metastatic RET fusion-positive NSCLC. Patients received pralatinib treatment until disease progression or unacceptable toxicity.
The primary efficacy endpoints were overall response rate and duration of response, as determined by a blinded independent review committee (BIRC). In 107 treatment-naïve patients, the overall response rate was 78% (95% confidence interval: 68, 85), and the median duration of response was 13.4 months (95% confidence interval: 9.4, 23.1). In 130 patients who had previously received platinum-based chemotherapy, the overall response rate was 63% (95% confidence interval: 54, 71), and the median duration of response was 38.8 months (95% confidence interval: 14.8, not estimable).
Indications for pralatinib (Gavreto)
(1) Pralatinib (Gavreto) is indicated for adult patients with non-small cell lung cancer (NSCLC) confirmed by a FDA-approved assay to have metastatic rearrangement (RET) fusion-positive disease.
(2) Pravtinib (Gavreto) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are refractory to radioactive iodine (if radioactive iodine therapy is applicable).
Adverse Reactions of Pravtinib (Gavreto)
The most common adverse reactions (≥25%) include musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, fever, and cough.
Usual Dosage of Pravtinib (Gavreto)
The recommended dose of pralatinib is 400 mg orally once daily. It should be taken on an empty stomach (no food for at least 2 hours before and at least 1 hour after administration).
