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FDA Grants Pembrolizumab/Axitinib Combo Priority Review for Frontline RCC

Gina Columbus @ginacolumbusonc
Published: Friday, Feb 15, 2019

Roger M. Perlmutter, MD, PhD

Roger M. Perlmutter, MD, PhD
The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for the combination of pembrolizumab (Keytruda) and axitinib (Inlyta) as a frontline treatment for patients with advanced renal cell carcinoma (RCC).1

Moreover, 25.9% of patients who were treated with pembrolizumab/axitinib discontinued treatment of either drug, compared with 10.1% of patients who discontinued sunitinib. A total 8.2% of patients discontinued treatment with both pembrolizumab and axitinib.


  1. FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma. Merck. Published February 15, 2019. Accessed February 15, 2019.
  2. Powles T, Plimack ER, Stus V, et al. Pembrolizumab plus axitinib vs sunitinib as first-line therapy for advanced renal cell carcinoma: KEYNOTE-426. J Clin Oncol. 2019;37 (suppl; abstr 543).
  3. Atkins MB, Plimack ER, Puzanov I, et al. Safety and efficacy of axitinib (axi) in combination with pembrolizumab (pembro) in patients (pts) with advanced renal cell cancer (aRCC). J Clin Oncol. 2018;36 (suppl; abstr 579). doi: 10.1200/JCO.2018.36.6_suppl.579.

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