The US Food and Drug Administration has approved abiraterone acetate (Zytiga) tablets in combination with prednisone for the treatment of metastatic prostate cancer patients with high-risk, castration-sensitive disease.
The FDA has expanded the approval of afatinib (Gilotrif) to include the first-line treatment of metastatic non–small-cell lung cancer patients whose tumors have non-resistant EGFR mutations, including three newly identified substitution mutations.
The FDA has expanded the approval of the PARP inhibitor olaparib (Lynparza) to include the treatment of patients with metastatic breast cancer who have a mutated BRCA gene.
The FDA has expanded the approval of vemurafenib (Zelboraf) to include the treatment of Erdheim–Chester disease in adult BRAF V600–positive patients. This marks the first approval from the agency for treating this rare blood cancer.
The FDA has granted accelerated approval to acalabrutinib (Calquence) for the treatment of mantle cell lymphoma in adult patients who have received at least one previous therapy.
The FDA has approved the CAR T-cell therapy axicabtagene ciloleucel (Yescarta) for the treatment of large B-cell lymphomas in adults who have failed or relapsed after two or more prior treatments.
The FDA has granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib.
Women with increased levels of cadmium, which mimics estrogen in the body, had a higher risk of endometrial cancer, according to a recently published observational study.
The FDA has approved a fixed combination of daunorubicin and cytarabine (Vyxeos) for the treatment of newly diagnosed therapy-related acute myeloid leukemia (AML) as well as AML with myelodysplasia-related changes.
The FDA Oncologic Drugs Advisory Committee has unanimously voted to recommend approval of the trastuzumab biosimilar MYL-1401O for the treatment of HER2-positive breast cancer.