On April 28, 2017, the FDA approved brigatinib (Alunbrig; Takeda), an oral kinase inhibitor, for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) with ALK mutation whose disease progressed during crizotinib therapy or who are intolerant to crizotinib therapy.
On April 17, 2017, atezo­lizumab (Tecentriq; Genentech), a PD-L1–blocking antibody, received a new indication by the FDA as first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
On March 23, 2017, the FDA accelerated the approval of avelumab (Bavencio; EMD Serono/Pfizer), PD-L1–blocking antibody, for the treatment of adults and pediatric patients aged ≥12 years with metastatic Merkel-cell carcinoma.
On July 11, 2017, the FDA approved an expanded indication for blinatumomab (Blincyto; Amgen) to include the treatment of patients with Philadelphia chromosome (Ph)-positive (Ph+), relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
On June 16, 2017, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with pomalidomide (Pomalyst) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 2 previous therapies, including lenalidomide (Rev­limid) and a proteasome inhibitor.
On July 12, 2017, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of Novartis’s CTL019 (tisagenlecleucel)—the first ever chimeric antigen receptor (CAR) T-cell therapy to be presented to the FDA for review for the treatment of pediatric patients and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
On June 29, 2017, the FDA authorized the marketing of ClearLLab Reagents (from Beckman Coulter, Inc), the first test that is agency approved to aid flow cytometry in the marking and detecting of several blood cancers
On May 1, 2017, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca) for the treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease progressed during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment.
On May 23, 2017, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) for the treatment of metastatic, microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed after previous treatment and have no appropriate alternative treatments, or for colorectal cancer that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
The FDA approved ribociclib, in combination with an aromatase inhibitor, for the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.
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