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# Blueprint Rolling NDA for Lung Cancer Drug
- URL: https://www.fdaweb.com/blueprint-rolling-nda-for-lung-cancer-drug/
- Published: 2020-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:57:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145791

Blueprint Medicines says it has begun a rolling NDA submission for pralsetinib after reporting top-line data from a pralsetinib study in patients with RET fusion-positive non-small cell lung cancer (NSCLC). The ongoing Phase 1/2 ARROW clinical trial showed a 61% objective response rate (ORR) and prolonged durability in patients with RET fusion-positive NSCLC previously treated with platinum-based chemotherapy, according to the company. Blueprint says pralsetinib is a potent and highly selective once-daily oral inhibitor of RET fusions and mutations, including predicted resistance mutations.

Blueprint says it should complete the NDA submission in the first quarter. It also plans to submit an NDA for pralsetinib for treating patients with medullary thyroid cancer previously treated with an approved multi-kinase inhibitor in the second quarter of 2020.