The U.S. Food and Drug Administration approved abermacicib (Verzeno; Eli Lilly) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Read full press release. 

The U.S. Food and Drug Administration approved apalutamide (Erleada; Janssen) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Read full press release. 

The U.S. Food and Drug Administration approved abiraterone acetate (Zytiga, Janssen Biotech, Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). Read full press release.

The U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza; AstraZeneca) a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Read full press release. 

The U.S. Food and Drug Administration granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (Opdivo; Bristol-Myers Squibb) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Read full press release.

The U.S. Food and Drug administration granted regular approval to pertuzumab (Perjeta; Genentech) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Read full press release.

The U.S. Food and Drug Administration granted regular approval to obinutuzumab (Gazyva; Genentech) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II buly; III, or IV follicular lymphoma (FL). Read full press release.

The U.S. Food and Drug Administration approved emicizumab-kxwh (Hemlibra; Genentech) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congential factor VIII deficiency) with factor VIII inhibitors. Read full press release. 

The U.S. Food and Drug Administration granted regular approval to brentuximab vedotin (Adcetris; Seattle Genomics) for the treatment of adult-patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systematic therapy. Read full press release. 

The U.S. Food and Drug Administration granted regular approval to dasatinib (Sprycel; Bristol-Myers Squibb) for the treatment of pediatric patients with Philadelphia chromosome-positive (PH+) chronic myeloid leukemia (CML) in the chronic phase. Read full press release.