Blueprint Medicines (NASDAQ:BPMC) initiates its rolling NDA filing for pralsetinib (BLU-667) for RET fusion-positive non-small cell lung cancer (NSCLC). It expects to complete the submission this quarter.
Topline data from a Phase 1/2 clinical trial, ARROW, showed a 61% overall response rate (ORR) per independent review. The ORR was 73% in treatment-naïve patients. Median duration of response was not reached at data cutoff. No new safety signals were reported.
Complete results will be submitted for presentation at a future medical conference.
A Phase 3 study, AcceleRET Lung Trial, in treatment-naïve RET fusion-positive NSCLC should launch in the coming weeks.
Pralsetinib is an orally available selective inhibitor of the proto-oncogene RET (rearranged during transfection) which plays a key role in the progression of a range of cancers including NSCLC and medullary thyroid cancer.
Shares down 1% premarket.
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