Shots:
- The US FDA has approved Welireg for the treatment of pts (≥12yrs.) with advanced, unresectable, or metastatic pheochromocytoma & paraganglioma (PPGL)
- Approval was based on Cohort A1 data from P-II (LITESPARK-015) trial assessing Welireg monotx. (120mg; QD) in 72 pts with unresectable or non-curable PPGL & stable blood pressure (BP <150/90 mm Hg, <135/85 mm Hg for adolescents), with no changes in antihypertensive therapy for at least 2wks. before treatment
- Trial showed significant ORR (1EP) improvement measured by BICR using RECIST v1.1, with favorable safety
Ref: Merck | Image: Merck | Press Release
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