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FDA Grants Pembrolizumab/Lenvatinib Breakthrough Designation for RCC

Jason M. Broderick @jasoncology
Published: Tuesday, Jan 09, 2018

Dr. Roy Baynes

Roy Baynes, MD, PhD
The FDA has granted the combination of the PD-1 inhibitor pembrolizumab (Keytruda) and the VEGF/FGF inhibitor lenvatinib (Lenvima) a breakthrough therapy designation for the treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).

ORR at 24 weeks was 83% (95% CI, 52-98) in the treatment-naïve cohort, and 50% in those patients who received previous treatment. All responses were partial responses. Two patients in the treatment-naïve group and 8 in the previously-treated population had stable disease. One patient in each cohort had primary progressive disease.
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