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Approved Drugs FDA has approved a supplemental new drug propelled, joystick-controlled, easy-to-use application (sNDA) for Xtandi® colonoscope system. • The Food and Drug Administration (FDA) (enzalutamide) capsules in advanced has approved a supplemental biologics prostate cancer. • Varian Medical Systems (varian.com) has license application (sBLA) for the use of received 510(k) clearance from the FDA to Arzerra® () (Genmab A/S, market the Nexus DR, a high resolution genmab.com) in combination with Drugs in the News imaging system for X-ray imaging using a fludarabine and cyclophosphamide for the digital X-ray detector. treatment of patients with relapsed chronic • (gene.com) has received a lymphocytic leukemia (CLL). second breakthrough therapy designation Approved Genetic Tests & from the FDA for Alecensa® () Assays • Amgen (amgen.com) announced that the for the treatment of adult patients with FDA has approved the sBLA for Blincyto® advanced ALK-positive NSCLC who have • AstraZeneca (astrazeneca-us.com) (blinatumomab) to include new data not received prior treatment with an ALK announced that the FDA has approved a supporting the treatment of pediatric patients inhibitor. blood-based companion diagnostic for with Philadelphia chromosome-negative (Ph-) Tagrisso® (). relapsed or refractory B-cell precursor acute • AbbVie (abbvie.com) submitted an sNDA lymphoblastic leukemia (ALL). to the FDA for Imbruvica® () to treat patients with marginal zone lymphoma, • Merck Sharp & Dohme Corp.’s (merck.com) a form of non-Hodgkin’s lymphoma. FDA Approves Two-Dose Keytruda® () has received Vaccination Regime FDA approval in first-line non-small cell lung • Fate Therapeutics, Inc. (fatetherapeutics. The FDA has approved a 2-dose cancer (NSCLC). The FDA also broadened com) announced that the FDA has granted vaccination regimen for Gardasil® 9 Keytruda’s label, approving the drug for use orphan drug designation for ProTmuneTM (Human Papillomavirus 9-valent in patients whose tumors express any level for “prevention of graft-versus-host disease Vaccine, Recombinant), for use in girls of PD-L1 in the second-line setting. Keytruda in patients undergoing allogeneic hemato- and boys 9 through 14 years of age. has also been granted accelerated approval poietic cell transplantation.” by the FDA for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease Approved Devices FDA Modifies the Indication progression on or after platinum-containing for Tarceva chemotherapy. • Medeon Biodesign, Inc. (medeonbio.com/ FDA modified the indication for Tarceva® en) has received FDA 510(k) clearance for () (Astellas Pharma US, Inc., TM • The FDA has approved Genentech’s (gene. AbClose , a single use, disposable us.astellas.com) for the treatment of ® com) Tecentriq (atezolizumab) for people laparoscopic port site closure device. NSCLC to limit use to patients whose with a specific type of metastatic NSCLC. tumors have specific epidermal growth • GI View Ltd. (giview.com) has received FDA factor receptor (EGFR) mutations. • Astellas Pharma US, Inc. (us.astellas.com) 510(k) clearance for the new Aer-O-Scope® and Pfizer Inc. (Pfizer.com) announced the Colonoscope System, a disposable, self-

20 accc-cancer.org | November–December 2016 | OI