lunes, 18 de agosto de 2014

FDA Approval Summary: Vemurafenib for Treatm... [Clin Cancer Res. 2014] - PubMed - NCBI

FDA Approval Summary: Vemurafenib for Treatm... [Clin Cancer Res. 2014] - PubMed - NCBI



 2014 Aug 5. pii: clincanres.0776.2014. [Epub ahead of print]

FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAF V600E Mutation.

Abstract

On August 17, 2011, the FDA approved vemurafenib tablets (ZELBORAF, Hoffmann-LaRoche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by an FDA-approved test. The cobas® 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.) was approved concurrently. An international, multicenter, randomized, open-label trial in 675 previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma allocated 337 patients to receive vemurafenib 960 mg orally twice daily and 338 patients to receive dacarbazine 1000 mg/m2 intravenously every 3 weeks. Overall survival (OS) was significantly improved in patients receiving vemurafenib [hazard ratio (HR) 0.44; 95% CI, 0.33-0.59; p< 0.0001)]. Progression-free survival (PFS) was also significantly improved in patients receiving vemurafenib (HR 0.26; 95% CI, 0.20-0.33; p<0.0001). Overall response rates (ORR) were 48.4% and 5.5% in the vemurafenib and dacarbazine arms, respectively. The most common adverse reactions (≥30%) in patients treated with vemurafenib were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, and nausea. Cutaneous squamous cell carcinomas (cuSCC) or keratoacanthomas were detected in approximately 24% of patients treated with vemurafenib. Other adverse reactions included hypersensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, uveitis, QT prolongation, and liver enzyme laboratory abnormalities.
Copyright © 2014, American Association for Cancer Research.

PMID:
 
25096067
 
[PubMed - as supplied by publisher]

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