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 approved brentuximab vedotin (Adcetris) for the treatment of primary cutaneous anaplastic large-cell lymphoma and CD30-expressing mycosis fungoides in patients who have received prior systemic therapy.
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.
The FDA has approved gemtuzumab ozogamicin (Mylotarg) for the first-line treatment of adults with CD33-positive AML and for pediatric patients with relapsed or refractory CD33-positive AML.
The FDA has approved the novel PI3K inhibitor copanlisib (Aliqopa) for the treatment of relapsed follicular lymphoma in adult patients who have received at least two prior systemic therapies.