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Eisai's Cancer Drug Combo Gets Breakthrough Therapy Designation For Liver Cancer

Eisai's Cancer Drug Combo Gets Breakthrough Therapy Designation For Liver Cancer

Japanese drug maker Eisai Co., Ltd (OTC: ESALY) has some positive news concerning one of its pipeline candidates.

What Happened

Eisai said the FDA has granted Breakthrough Therapy Designation for Lenvima, its orally available kinase inhibitor, in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment.

Eisai noted this is the third BTD for Lenvima-Keytruda combination, the first two granted for advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high proficient mismatch repair endometrial carcinoma.

Why It's Important

The BTD is intended to expedite the development and review of medicines for serious or life-threatening conditions. To get the designation a therapy should demonstrate that it may provide substantial improvement over currently available therapy on at least one clinically significant endpoint.

"We are dedicated to working together with Merck & Co., Kenilworth, N.J., U.S.A. to potentially bring another important option to patients," said Takashi Owa, VP, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai.

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