The U.S. Food and Drug Administration approved olaparib (Lynparza; AstraZeneca) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev; Astellas) for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Read full press release.

The U.S. Food and Drug Administration approved enzalutamide (Xtandi; Astellas) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Read full press release.

The U.S. Food and Drug Administration approved atezolizumab (Tecentriq; Genentech) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Read full press release. 

The U.S. Food and Drug Administration approved acalabrutinib (Calquence; AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read full press release. 

The U.S. Food and Drug Administration approved crizanlizumab-tmca (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa; BeiGene) for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Read full press release.

The U.S. Food and Drug Administration approved luspatercept-aamt (Reblozyl; Celgene) for treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. Read full press release. 

The U.S. Food and Drug Administration approves Ziextenzo (pegfilgrastim-bmez).  Ziextenzo, a biosimilar of Neulasta, is a long-acting G-CSF indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Read full press release.