January 25, 2018

Breakthrough Therapy Designation Awarded by FDA for Lenvima and Keytruda Combination Treatment for Advanced Renal Cell Carcinoma

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CancerConnect News: The U.S. Food and Drug Administration (FDA) has announced “Breakthrough Therapy Designation” for the multiple receptor tyrosine kinase inhibitor Lenvima® (lenvatinib) in combination with Keytruda® (pembrolizumab) for the potential treatment of patients with advanced renal cell carcinoma (RCC).

About Renal Cell Carcinoma

Each year in the United States, more than 61,000 people are diagnosed with kidney cancer. The most common type of kidney cancer is RCC, which starts in the lining of very small tubes (tubules) in the kidney. For people with advanced or metastatic RCC (cancer that has spread to other parts of the body), targeted therapies can play an important role in treatment. Approximately 20-30% of patients with RCC will have metastases at diagnosis and as many as 40% will demonstrate metastasis after treatment for earlier stage RCC. With a 5-year survival rate ranging from 5-10% for patients with advanced RCC, the overall prognosis for these patients is poor.

About Lenvima®

Lenvima® is a multi-kinase inhibitor that is currently FDA approved for treatment of advanced thyroid cancer and RCC in combination with Afinitor (everolimus).  Lenvima is a receptor tyrosine kinase (RTK) inhibitor that that stops or decreases the action of many different cellular processes involved in cancer growth or spread. Lenvima is thought to inhibit or decrease the action of VEGFR1 (FLT1), VEGFR2 (KDR), VEGFR3 (FLT4); FGFR1, 2, 3, and 4; PDGFRα, KIT, and RET.

About Keytruda ®

Keytruda belongs to a class of precision cancer immunotherapy medications referred to as “checkpoint inhibitors” that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

The Breakthrough Therapy Designation is an FDA program intended to expedite development and review of drugs 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 Breakthrough Therapy Designation include more intensive guidance on an efficient drug development program, access to a regulatory liaison to help accelerate review time and eligibility for rolling review as well as priority review.

Reference:  http://www.prnewswire.com/news-releases/eisai-and-merck-receive-breakthrough-therapy-designation-from-fda-for-lenvima-lenvatinib-mesylate-and-keytruda-pembrolizumab-as-combination-therapy-for-advanced-andor-metastatic-renal-cell-carcinoma-300579517.html

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Tags: immunotherapy, keytruda, lenvatinib, Lenvima, News, pembrolizumab, Precision Cancer Medicine, Renal Cancer, renal cell cancer, Uncategorized