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.
- 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. https://on.mktw.net/2tpI7Qm. Accessed February 15, 2019.
- 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).
- 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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