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.
Castle Biosciences IPO: What You Need To Know
The Daily Biotech Pulse: Acadia Schizophrenia Drug Fails, Viveve Plummets
See more from Benzinga
- The Daily Biotech Pulse: Acadia Schizophrenia Drug Fails, Viveve Plummets, Eisai Gets Breakthrough Therapy Designation
- The Week Ahead In Biotech: Pharma Earnings Pick Up Pace
- Merck's Novel Antibiotic For Abdominal, Urinary Tract Infections Receives FDA Nod
© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.