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FDA Grants Adjuvant Sunitinib Priority Review in High-Risk RCC

Jason M. Broderick @jasoncology
Published: Thursday, Jun 01, 2017

Dr. Mace Rothenberg

Mace Rothenberg, MD

The FDA has granted a priority review designation to sunitinib (Sutent) for use as an adjuvant therapy in patients with renal cell carcinoma (RCC) who have received nephrectomy and are high risk for recurrence.

Pfizer also reported in a press release that the European Medicines Agency validated for review a type II variation application for sunitinib for use in the same setting as the FDA application.

References

  1. Ravaud A, Motzer RJ, Pandha HS, et al. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy [published online October 10, 2016]. N Engl J Med. DOI: 10.1056/NEJMoa1611406.
  2. Ravaud A, Motzer RJ, Pandha HS, et al. Phase III trial of sunitinib (SU) vs placebo (PBO) as adjuvant treatment for high-risk renal cell carcinoma (RCC) after nephrectomy (S-TRAC). Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract for LBA11.

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