FDA Approves Eisai’s Combination Therapy for Renal Cancer


Lenvima® (lenvatinib) of Eisai Inc., the U.S. pharmaceutical subsidiary of Tokyo based Eisai Co., Ltd., procured U.S. FDA approval for the treatment of advanced renal cell carcinoma (aRCC) in combination with everolimus in patients who have earlier received an anti-angiogenic therapy.

The FDA approval was followed by Breakthrough Therapy designation and Priority Review by the FDA.

eisai japan logoThe remarkable results of the Phase II trials-Study 205 laid the foundation of the FDA approval. Once-daily, oral administration of 18mg Lenvima® in combination with 5mg everolimus demonstrated nearly three times improvement in progression-free survival (PFS), significant objective response rate (ORR) and clinically substantial overall survival (OS) compared to administration of everolimus alone which is a standard care given to aRCC patients with a prior anti-angiogenic therapy.

lenvatinib renal cancer

63% reduction in the risk of disease progression was shown by the combination therapy versus everolimus alone.

Lenvatinib plus everolimus is the first and only FDA-approved regimen that successfully combines treatments that employ tyrosine kinase and mTOR inhibition, the primary targets of advanced RCC treatment for the past decade,” said Robert Motzer, M.D., Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study. “This combination regimen led to enhanced efficacy and helped patients with advanced RCC live longer without disease progression or death than those treated with everolimus alone. These noteworthy findings advance the treatment paradigm for this patient population“.

Lenvima® is a multiple kinase inhibitor against the vascular endothelial growth factor receptor (VEGFR 1-3) kinases. It was first approved in U.S. in Feb, 2015 for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC) patients. The synergistic effect of lenvatinib plus everolimus showed increased anti-angiogenic and anti-tumor activity.

renal cell cancer stages

Figure 1. Stages of renal cell carcinoma

Renal cell carcinoma is a most common type of incurable kidney cancer comprises around 90-95% cases. Malignant cells are formed in the lining of tubules in the kidney.

Apart from standard care drug everolimus, various targeted therapies have been approved by FDA for aRCC. Oral therapy, cabozantinib of Exelixis Inc. was approved by FDA last month. Other multiple kinase inhibitor, pazopanib; intravenous drug, temsirolimus of Wyeth Pharmaceuticals was also FDA approved for aRCC treatment.

Kinase inhibitor, sorafenib; recombinant humanized monoclonal antibody, bevacizumab; Pfizer’s tyrosine kinase inhibitor- sunitinib and axitinib; humanized IgG4 anti-PD-1 monoclonal antibodynivolumab are also some FDA approved targeted therapeutics which affect the growth factors responsible for the growth and propagation of tumors.

Rates of renal cell carcinoma have been on the rise over the past several decades, and unfortunately, advanced RCC remains an incurable disease. Since the VEGF pathway is known to be involved in the growth of renal cell tumors, it is important to have a diverse offering of therapeutic options, including treatments that continue to target VEGF inhibition,” said Sumanta Kumar Pal, M.D., Assistant Professor, Department of Medical Oncology & Therapeutics Research and Co-Director, Kidney Cancer Program at City of Hope in Duarte, Calif.The combination regimen of lenvatinib and everolimus provides a new treatment for patients with advanced RCC whose disease continues to progress despite prior treatment with an anti-angiogenic therapy“.

Featured Image: Human Kidneys © Eraxion (Stock Photo ID: 3192161)

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