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FDA Grants Breakthrough Status to Lenvatinib/Pembrolizumab for Endometrial Cancer

Jason M. Broderick @jasoncology
Published: Wednesday, Aug 01, 2018

Dr. Roy Baynes

Roy Baynes, MD, PhD
The FDA has granted a breakthrough therapy designation to the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.

“This second breakthrough therapy designation for the Lenvima/Keytruda combination represents another step forward in our collaboration with Eisai and supports the continued evaluation of this combination in more than 11 types of cancer,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a statement. “We will continue to work closely with Eisai to build on the robust data for the Lenvima/Keytruda combination in advanced endometrial carcinoma in an effort to offer a new option for these patients and potentially help address a critical unmet need.”
Makker V, Rasco DW, Vogelzang NJ, et al. Lenvatinib + pembrolizumab in patients with advanced endometrial cancer: Updated results. J Clin Oncol. 2018;36 (suppl; abstr 5596).

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