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Eight important updates from the FDA

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

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

• The FDA granted ribociclib (LEE011, Novartis) breakthrough therapy designation for use in combination with letrozole for first-line treatment of patients with advanced or metastatic hormone receptor–positive, HER-2–negative breast cancer. Read more.
• Granisetron (Sustol, Heron Therapeutics) received FDA approval for use in combination with other antiemetics to prevent acute or delayed chemotherapy-induced nausea and vomiting in adults. Read more.
• The FDA granted breakthrough therapy designation to daratumumab (Darzalex, Janssen) — a CD38-directed monoclonal antibody — for its use in combination with standard-of-care regimens for patients with previously treated multiple myeloma. Read more.
• The FDA expanded its approval of pembrolizumab (Keytruda, Merck) to include treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy. Read more.
• CRLX101(Cerulean Pharma) — a nanoparticle-drug conjugate — received fast track designation for its use in combination with paclitaxel for the treatment of platinum-resistant ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer. Read more.
• The FDA granted fast track designation to axalimogene filolisbac (Advaxis) for the adjuvant treatment of high-risk locally advanced cervical cancer. Read more.
• The FDA granted breakthrough therapy designation to LOXO-101 (Loxo Oncology) for the treatment of unresectable or metastatic solid tumors with neurotrophic tyrosine receptor kinase gene fusions. Read more.
• TK216 (Oncternal Therapeutics) received orphan drug designation for the treatment of Ewing sarcoma, a rare pediatric cancer comprised of highly malignant, undifferentiated tumors of bone. Read more.