FDA Approves Ivosidenib for Frontline Acute Myeloid Leukemia
May 2nd 2019The FDA has approved a supplemental new drug application (sNDA) for ivosidenib (Tibsovo) as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia (AML), as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.
Darolutamide Granted a Priority Review for Nonmetastatic Castration-Resistant Prostate Cancer
April 29th 2019The FDA has granted a priority review designation to a new drug application (NDA) for darolutamide for use as a treatment for patients with nonmetastatic castration-resistant prostate cancer (CRPC).
FDA Expands Pembrolizumab Approval for Lung Cancer
April 12th 2019The FDA has expanded the approval for pembrolizumab (Keytruda) monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer (NSCLC), who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression (tumor proportion score [TPS]) level of ≥1% and do not harbor EGFR or ALK aberrations.