8/10/2023 0 Comments Blueprint medicines![]() In 27 treatment-naive patients who were ineligible for platinum-based chemotherapy, the ORR was 70%, with an 11% complete response rate, and the median DOR was 9 months. In 87 patients previously treated with platinum chemotherapy, the ORR was 57% with a 5.7% complete response rate, and the median DOR was not estimable. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR). The phase 1/2 ARROW clinical trial evaluated Gavreto in patients with RET fusion–positive metastatic NSCLC. When used for MTC or thyroid cancer, it is approved for patients 12 years and older. When used for NSCLC, Gavreto is approved for adult patients only. Only patients with a gene mutation or RET gene fusion should receive treatment with Gavreto. Counsel patients to avoid food consumption for at least 2 hours before and at least 1 hour after their doses. ![]() The recommended dosage of Gavreto is 400 mg orally once daily on an empty stomach. Gavreto displays a mean elimination half-life of 15.7 hours after a single dose and 20 hours after multiple doses. Gavreto reaches steady-state concentrations after 3 to 5 days of treatment. After a single oral dose, the median time to peak concentration is 2 to 4 hours. Gavreto is a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations. Its continued approval may be contingent upon additional confirmatory trials. 2 Gavreto received an accelerated approval based on the overall response rate and duration of response. Approximately 1% to 2% of patients with NSCLC and 10% to 20% of patients with papillary thyroid cancer cases have RET fusion–positive tumors, and approximately 90% of patients with advanced MTC harbor RET mutations. 1 RET fusions and mutations drive many types of cancer. The FDA has approved GAVRETO (pralsetinib) from Blueprint Medicines Corporation for the treatment of metastatic RET fusion–positive non–small cell lung cancer (NSCLC) as detected by an agency-approved test, advanced or metastatic RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy, and advanced or metastatic RET fusion–positive thyroid cancer requiring systemic therapy in patients who are radioactive iodine refractory. ![]()
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