Biotechnology Healthcare - June 2008 - (Page 8) DRUG TRACK SELECTED FDA BIOLOGIC DRUG AND DIAGNOSTIC APPROVALS, DEC. 2007–APRIL 2008 Action date Drug name (Trade name) Sponsor Indication Dosage form Biologics license approval Feb. 21, 2008 antihemophilic factor (recombinant), plasma/ albumin-free (Xyntha) Wyeth Control and prevention of bleeding and for surgical prophylaxis in patients with hemophilia A Intravenous injection New drug approvals Dec. 14, 2007 thyrotropin alfa (Thyrogen) Genzyme Adjunctive treatment for radioiodine ablation of thyroid Intramuscular tissue remnants in patients who have undergone thy- injection roidectomy for well-differentiated thyroid cancer and who have no evidence of metastatic thyroid cancer Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome Chronic lymphotic leukemia Reducing signs and symptoms of and maintaining clinical response in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy Subcutaneous injection Infusion Subcutaneous injection Feb. 27, 2008 March 20, 2008 April 22, 2008 rilonacept (Arcalyst) Regeneron bendamustine (Treanda) Cephalon certolizumab pegol (Cimzia) UCB New or expanded indications Jan. 14, 2008 Jan. 18, 2008, and Feb. 21, 2008 Feb. 22, 2008 natalizumab (Tysabri) Biogen Idec/Elan Abbott Laboratories Moderate-to-severe Crohn’s disease in patients with Infusion evidence of inflammation and with inadequate response to, or intolerance of, conventional Crohn’s therapies* Jan. 18: Moderate to severe plaque psoriasis in patients not suitable for other systemic therapies Feb. 21: Reducing signs and symptoms of moderate to severe JIA in patients age ≥4 In combination with paclitaxel in patients who have not received chemotherapy for metastatic HER2negative breast cancer Subcutaneous injection adalimumab (Humira) bevacizumab (Avastin) Genentech Infusion Molecular test approval Jan. 14, 2008 TOP2A FISH pharmDx Dako Denmark Detect amplifications/deletions of the TOP2A gene as marker for poor prognosis in high-risk BC patients Fluorescence in situ hybridization *Crohn’s disease patients using the drug must be enrolled in a special restricted distribution program called the Crohn’s Disease-Tysabri Outreach United Commitment to Health (CD TOUCH) Prescribing Program. BC=breast cancer, HER2= human epidermal growth factor receptor 2, JIA=juvenile idiopathic arthritis. Sources: FDA, Manufacturers’ package inserts mumab (Vectibix) combined with chemotherapy as first- and secondline treatments for metastatic colorectal cancer. Panitumumab is approved as monotherapy for epidermal growth factor receptorexpressing colorectal cancer that has progressed after chemotherapy. … The National Cancer Institute of Canada Clinical Trials Group did not permit a study of cediranib (Recentin) as first-line therapy for nonsmall cell lung cancer (NSCLC) to continue into phase 3 due to toxicity findings. For AstraZeneca, however, the news about its vascular endothelial growth factor inhibitor was not all bad; positive results from a phase 2/3 study comparing cediranib to bevacizumab, when both are combined with chemotherapy to treat metastatic colorectal cancer, means investigation of this use will continue to phase 3. A phase 3 evaluation of sorafenib (Nexavar) in patients with NSCLC ended early when the drug failed to improve overall survival. Sorafenib, approved for treatment of advanced kidney cancer and nonoperable liver cancer, has shown poor results for skin cancer but is under investigation for use in other malignancies. Rheumatology trials Two phase 3 studies presented at the American College of Rheumatology confirm that rheumatoid arthritis (RA) remains a hotbed of drug development. In combination with methotrexate, certolizumab pegol (Cimzia), UCB’s pegylated Fc-free tumor necrosis factor-α inhibitor, was significantly more effective than methotrexate alone for 8 BIOTECHNOLOGY HEALTHCARE · MAY/JUNE 2008
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