News

The 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.

The 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.

The Food and Drug Administration (FDA) expanded the approved use of palbociclib (Ibrance) capsules plus endocrine therapy to treat male patients with hormone receptor (HR)–positive, HER2-negative advanced or metastatic breast cancer, according to an announcement by the agency.