
FDA Grants Priority Review to a new antineoplastic agent: What It Means for Breast Cancer Patients
Summary The FDA has granted Priority Review to a first-in-class PI3K/mTOR inhibitor for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer. This milestone signals a potential shift in second-line treatment options globally, including for patients in Malaysia. FDA Priority Review: The U.S. FDA has accepted the NDA under Priority Review with














