CANCER DIGEST – Feb. 10, 2016 – Patients with a type of kidney cancer that has spread to other parts of the body despite surgery and chemotherapy may soon have a new treatment option.
The FDA granted Priority Review for a drug called lenvatinib (Lenvima®) for treatment in combination with the drug everolimus for kidney cancer that has failed to respond to surgery and prior chemotherapy.
The drug made by Japanese pharmaceutical company Eisai had previously been approved in the US and Europe for treatment of some forms of thyroid cancer, and was previously given the FDA’s Breakthrough Therapy designation, which is reserved for drugs with preliminary clinical evidence indicating the drug used alone or in combination with other drugs, may demonstrate a substantial improvement over existing therapies. There is no guarantee that this investigational use will eventually be successful in gaining FDA approval.
The drug is promising because it blocks or inhibits several receptors for cell enzymes called tyrosine kinases, which play a key role in activating the signaling within the cell that triggers cell division.
The priority review status means the drug will get expedited evaluation of the drug tests aimed at gaining approval. Drugs given priority review must offer the potential of a significant improvement in outcomes compared to current treatments.
Approximately 16 percent of patients with renal cell cancer will have cancer spread beyond the kidney at diagnosis and as many as 40 percent will see the cancer spread after primary surgical treatment for localized tumors. The result is a poor prognosis for these patients with only 5 to 12 percent surviving 5 years after diagnosis.
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