FDA Drug Approvals and Changes: December Edition

Mary L Windle, PharmD

December 19, 2014


Contributor Information


Mary L Windle, PharmD
Editor-in-Chief, Medscape Drug Reference


  1. Topp MS, et al. Phase II Trial of the Anti-CD19 Bispecific T Cell-Engager Blinatumomab Shows Hematologic and Molecular Remissions in Patients With Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia. J Clin Oncol. 2014 Nov 10.
  2. Topp MS. Confirmatory open-label, single-arm, multicenter phase 2 study of the BiTE antibody blinatumomab in patients (pts) with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL). Presented at the 2014 ASCO Annual Meeting, May 30 - June 3, 2014; Chicago, IL. J Clin Oncol. 32:5s, 2014 (suppl; abstr 7005).
  3. Cohen JA, Coles AJ, Arnold DL, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: A randomised controlled phase 3 trial. Lancet. 2012; 380: 1819-28.
  4. Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: A randomised controlled phase 3 trial. Lancet. 2012; 380: 1829-39.
  5. Sterling TR, et al. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. Dec 8;2011(23);365:2155-66.
  6. Centers for Disease Control and Prevention. Recommendations for use of an isoniazid-rifapentine regimen with direct observation to treat latent Mycobacterium tuberculosis infection. MMWR Morb Mortal Wkly Rep. 2011 Dec 9;60(48):1650-3.
  7. Verstovsek S, Kiladjian J, Griesshammer M, et al. Results of a prospective, randomized, open-label phase 3 study of ruxolitinib (RUX) in polycythemia vera (PV) patients resistant to or intolerant of hydroxyurea (HU): the RESPONSE trial. Presented at the 2014 ASCO Annual Meeting, May 30 - June 3, 2014; Chicago, IL. J Clin Oncol. 32:5s, 2014 (suppl; abstr 7026).
  8. Pujade-Lauraine E, et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8.
  9. Fu D, et al. Paliperidone palmitate delays relapse in patients with schizoaffective disorder (abstract NR8-133). Presented at the 167th American Psychiatric Association Annual Meeting; May 6, 2014. New York, NY.
  10. Lawitz E, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014 Jul 26. pii: S0140-6736(14)61036-9.
  11. Wilke H, Van Cutsem E, Oh SC, et al. RAINBOW: A global, phase III, randomized, double-blind study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in the treatment of metastatic gastroesophageal junction (GEJ) and gastric adenocarcinoma following disease. progression on first-line platinum- and fluoropyrimidine-containing combination therapy. J Clin Oncol. 2014;32 (3_suppl):Abstract LBA7.
  12. Hu MI. Denosumab for treatment of hypercalcemia of malignancy. J Clin Endocrinol Metab. 2014; 99(9):3144-52.
  13. Kane JM, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Nov;75(11):1254-60.
  14. Stein Gold LF, et al. Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials. J Drugs Dermatol. 2013 Aug;12(8):911-18.
  15. Joura E, et al. Efficacy and immunogenicity of a novel 9-valent HPV L1 virus-like particle vaccine in 16- to 26-year-old women. Abstract (SS 8-4) presented at EUROGIN 2014 November 5, 2013.