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Eight noteworthy FDA actions

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The FDA announced several decisions related to hematology and oncology therapies and devices in the past month.

HemOnc Today summarizes eight FDA actions that may be relevant to your practice.

• The FDA cleared Paxman Coolers Limited to market the Paxman Scalp Cooling System, designed to reduce hair loss among patients with breast cancer who undergo chemotherapy. Read more.
• CTL019 (Novartis) — an investigational chimeric antigen receptor T-cell therapy — received breakthrough therapy designation for the treatment of adults with relapsed and refractory diffuse large B-cell lymphoma who failed two or more prior therapies. Read more.
• The FDA granted accelerated approval to atezolizumab (Tecentriq, Genentech) for the initial treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Read more.
• Ganitumab (AMG 479, NantCell) — a fully human monoclonal antibody directed against insulin growth factor-1R — received orphan drug designation for the treatment of Ewing sarcoma. Read more.
• The FDA granted marketing authorization to ipsogen JAK2 RGQ PCR Kit (Qiagen) — a qualitative in vitro diagnostic test for real-time polymerase chain reaction on the Rotor-Gene Q MDx instrument (Qiagen) — to detect the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. Read more.
• The FDA accepted for review a supplemental new drug application for ibrutinib (Imbruvica; Pharmacyclics, Janssen) for the treatment of patients with chronic graft-versus-host disease who failed at least one prior line of systemic therapy. Read more.
• Yeliva (ABC294640, RedHill Biopharma) — a first-in-class, orally administered, sphingosine kinase-2 selective inhibitor with anticancer and anti-inflammatory activities — received orphan drug designation for the treatment of cholangiocarcinoma. Read more.
• The FDA approved a supplemental new drug application for use of palbociclib (Ibrance, Pfizer) as initial endocrine therapy for postmenopausal women with hormone receptor–positive, HER-2–negative advanced or metastatic breast cancer. Read more.