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FDA Approves Pralsetinib for Locally Advanced, Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
On August 9, 2023, The US Food and Drug Administration (FDA) approved pralsetinib for adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
In September of 2020, pralsetinib was granted accelerated approval in the NSCLC indication based on overall response rate (ORR) and duration of response (DOR) data from a subgroup of 114 patients enrolled in the multi-center, open-label, multi-cohort phase 1/2 ARROW trial. This conversion to regular approval was based on follow-up data from the ARROW trial.
In the follow-up analysis, 123 patients were evaluated for durability of response (DOR) and 237 patients were evaluated for efficacy. Patients received 400 mg pralsetinib once daily until disease progression or unacceptable toxicity. Primary end points included ORR and DOR as determined by a blinded independent review committee.
After 25 months of additional follow-up, the ORR among treatment-naïve patients (n = 107) was 78% and median DOR was 13.4 months. Among patients previously treated with platinum-based chemotherapy (n = 130) ORR was 63% and median DOR was 38.8 months. The most common adverse events occurring in ≥ 25% of patients included musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.
The recommended dose of pralsetinib is 400 mg orally once daily until disease progression or unacceptable toxicity. Pralsetinib should be taken on an empty stomach, at least 2 hours after food intake. Food should not be reintroduced until at least 1 hour after pralestinib administration.
Source:
FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions. US Food and Drug Administration. Published August 9, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pralsetinib-non-small-cell-lung-cancer-ret-gene-fusions
