FDA grants Priority Review to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
RHHBYRoche(RHHBY) globenewswire.com·2024-05-29 13:00

Priority Review recognises the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options1,2 Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting The target action date for the FDA decision is 27 November, 2024 Basel, 29 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Appl ...