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Journal Cover The Medical Letter
  [SJR: 0.142]   [H-I: 16]   [5 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0025-732X - ISSN (Online) 1523-2859
   Published by The Medical Letter, Inc Homepage  [1 journal]
  • In Brief: Cabozantinib (Cabometyx) for Advanced Renal Cell Carcinoma
           (online only)
    • Authors: admin
      Abstract: Date:  July 18, 2016 Issue #:  1499 Summary:  The FDA has approved the oral tyrosine kinase inhibitor cabozantinib (Cabometyx – Exelixis) for treatment of patients with advanced renal cell carcinoma previously treated with antiangiogenic therapy. Cabozantinib was first approved in 2012 as Cometriq for treatment of progressive, metastatic medullary thyroid cancer.

      Anti-VEGF antibodies, tyrosine kinase inhibitors, and mTOR kinase inhibitors have become the standard of care for treatment of unresectable or metastatic renal cell cancer.1

      FDA approval was based on the results of a randomized open-label trial (METEOR) comparing cabozantinib to everolimus in 658 patients with advanced or metastatic renal cell carcinoma that had progressed on antivascular endothelial growth factor receptor (VEGFR) therapy. In patients treated with cabozantinib, median progression-free survival was significantly longer (7.4 vs 3.8 months with everolimus) and the objective response rate was significantly higher (21% vs 5% with everolimus).2Median overall survival was 21.4 months with cabozantinib and 16.5 months with everolimus.3

      Common adverse effects of cabozantinib include diarrhea, fatigue, nausea, vomiting, weight loss, palmar-plantar erythrodysesthesia, and hypertension. Serious adverse effects, including GI perforation, hemorrhage, and arterial thromboembolic events, occurred in >60% of patients treated with cabozantinib in the clinical trial.

      The recommended dosage of cabozantinib is 60 mg taken once daily without food. Dosage adjustments are required for patients taking strong CYP3A4 inhibitors or inducers concomitantly.4 In patients who experience severe or intolerable adverse effects, reducing the dosage or withholding the drug until improvement occurs is recommended.


      Axitinib (Inlyta) for advanced renal cell carcinoma. Med Lett Drugs Ther 2012; 54:47.
      TK Choueiri et al. Cabozantinib versus everolimus in advanced renal-cell carcinoma. N Engl J Med 2015; 373:1814.
      TK Choueiri et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol 2016 June 3 (epub).
      Inhibitors and inducers of CYP enzymes and P-glycoprotein. Med Lett Drugs Ther 2016; 58:e46.

      Download complete U.S. English article


      PubDate: Mon, 11 Jul 2016 18:00:47 +000
       
  • Asfotase Alfa (Strensiq) for Hypophosphatasia (online only)
    • Authors: admin
      Abstract: Date:  July 18, 2016 Issue #:  1499 Summary:  The FDA has approved asfotase alfa (Strensiq – Alexion), a recombinant form of tissue-nonspecific alkaline phosphatase, for subcutaneous treatment of perinatal-, infantile-, and juvenile-onset hypophosphatasia. Asfotase alfa is the first treatment to be approved in the US for this rare genetic metabolic disorder.
      PubDate: Mon, 11 Jul 2016 17:39:46 +000
       
  • SGLT2 Inhibitors and Renal Function
    • Authors: admin
      Abstract: Date:  July 18, 2016 Issue #:  1499 Summary:  At the same time that the FDA announced it was strengthening existing warnings about the risk of acute kidney injury in patients with type 2 diabetes treated with the sodium-glucose co-transporter 2 (SGLT2) inhibitors canagliflozin (Invokana, and others) and dapagliflozin (Farxiga, and others), a study was published showing that the third SGLT2 inhibitor, empagliflozin (Jardiance, and others), slowed the progression of renal dysfunction in patients with type 2 diabetes.
      PubDate: Mon, 11 Jul 2016 15:42:46 +000
       
  • Buprenorphine Implants (Probuphine) for Opioid Dependence
    • Authors: admin
      Abstract: Date:  July 18, 2016 Issue #:  1499 Summary:  The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.
      PubDate: Wed, 29 Jun 2016 11:40:37 +000
       
  • Brivaracetam (Briviact) for Epilepsy
    • Authors: admin
      Abstract: Date:  July 18, 2016 Issue #:  1499 Summary:  Brivaracetam (Briviact – UCB), an analog of levetiracetam (Keppra, and others), has been approved by the FDA for adjunctive treatment of partial-onset seizures in patients ≥16 years old. New drugs for epilepsy are often approved initially only as adjunctive treatment for partial seizures.
      PubDate: Wed, 29 Jun 2016 11:40:07 +000
       
  • Onzetra Xsail - Sumatriptan Nasal Powder
    • Authors: admin
      Abstract: Date:  July 18, 2016 Issue #:  1499 Summary:  The FDA has approved Onzetra Xsail (Avanir), a nasal powder formulation of sumatriptan, for acute treatment of migraine in adults. Nasal spray formulations of sumatriptan (Imitrex) and zolmitriptan (Zomig) have been available for many years.
      PubDate: Wed, 29 Jun 2016 11:39:34 +000
       
 
 
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