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Eisai, Merck get FDA breakthrough therapy designation for Lenvima/Keytruda combination therapy

Eisai and Merck have received the Food and Drug Administration’s blessing for a breakthrough therapy designation for Lenvima (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab), the companies announced Tuesday. The combination therapy is indicated for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed following at least one prior systemic therapy.

This is the third breakthrough therapy designation for Lenvima and the second breakthrough therapy designation for Lenvima in combination with Keytruda, following the breakthrough therapy designation for the combination for advanced and/or metastatic renal cell carcinoma announced in January 2018.

The breakthrough therapy designation is an FDA program intended to expedite development and review of medicines for serious or life-threatening conditions. In order to qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. The benefits of this designation include more intensive guidance on an efficient clinical development program and access to senior FDA managers and experienced FDA staff to help accelerate review time, as well as eligibility for rolling review and potentially priority review.

“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,” said Roy Baynes, Merck Research Laboratories senior vice president and head of global clinical development, chief medical officer. “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.”

“We designed Study 111 to learn as much as we could about the Lenvima/Keytruda combination as efficiently as possible, driven by a sense of urgency to bring forward a potential new treatment option for patients in need,” said Eisai vice president and chief medicine creation officer, oncology business group Takashi Owa. “We are encouraged by the continued activity seen in patients with endometrial carcinoma, and the latest breakthrough therapy designation for Lenvima and Keytruda has strengthened our commitment as part of our human healthcare mission, to expedite the path to ultimately benefitting patients living with endometrial carcinoma as quickly as possible.”
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