FDA APPROVALS

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.

The U.S. Food and Drug Administration approved niraparib (Zejula; Tesaro), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Read full press release. 

The U.S. Food and Drug Administration approved daratumumab (Darzalex, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). Read full press release.

The U.S. Food and Drug Administration approved apalutamide (Erleada; Janssen) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. Read full press release.