FDA grants approval to Pralsetinib for NSCLC With RET Fusion Mutation

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By Dr. Anish Shah

Bronx-Lebanon Hospital


On August 9, 2023, the U.S. Food and Drug Administration granted regular approval to pralsetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) with RET (rearranged transfection) fusion.


Study ID number: NCT03037385


This approval was based on the ARROW trial, a multicenter, open-label, multi-cohort trial that included 237 patients with NSCLC with RET fusion. The drug was given accelerated approval in September 2020 based on an initial overall response rate and duration of response in 114 patients. Pralsetinib was given orally at 400 mg once daily until disease progression or unacceptable toxicity.


Efficacy was established on the overall response rate (ORR) and duration of response (DOR). For treatment-naïve patients, ORR was noted to be 78% (95% CI= 68 to 85) with a median DOR of 13.4 months (95% CI=9.4 to 23.1). Likewise, for patients previously treated with platinum-based chemotherapy: ORR was 63% (95% CI= 54 to 71) with a median DOR of 38.8 months (95% CI=14.8 to not estimable).


Common adverse reactions included fatigue, myalgia, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.


In conclusion, pralsetinib demonstrates significant efficacy in patients with RET fusion-positive NSCLC, both in treatment-naïve and those previously treated with platinum-based chemotherapy.

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