FDA Issues Breakthrough Therapy Designation for LENVIMA


The Eisai Co. Ltd. and Merck & Co. Inc. Kenilworth –has recently announced that the United States FDA (Food & Drug Administration) has granted the Breakthrough Therapy designation for LENVIMA (the generic name as Lenvatinib Mesylate) –the oral kinase inhibitor available out there developed by Eisai. The grant was also given for the anti-PD-1 therapy KEYTRUDA (with its generic name as Pembrolizumab) By Merck & Co. Inc. –used for treating the patients having advanced & metastatic non-microsatellite instability or pMMR (proficient mismatch repair) EC (endometrial carcinoma).

The therapy of the combination of LENVIMA & KEYTRUDA is currently under joint development by Eisai & Merck & Co. Inc. This is a part of the major strategic collaboration between the two companies that was announced in March 2018. This is going to be the 3rd Breakthrough Therapy designation for LENVIMA by FDA in combination with KEYRUDA. This designation is followed by the Breakthrough Therapy designation that took place for the combination of advanced & metastatic renal cell carcinoma that was announced earlier this year in January.

The Breakthrough Therapy designation is a distinctive FDA-run program that aims at expediting the reviewing and development of medicines for life-threatening or fatal life conditions. Towards qualifying for this specific FDA-approved designation, preliminary clinical evidence should be able to demonstrate that the particular drug might be providing sustainable improvements over the other currently existing therapies on at least one of the clinically important endpoints.

The main benefit of the Breakthrough Therapy designation by FDA includes focusing on more intensive treatment methods and guidance on the available, efficient clinical development & review programs