Japanese firm Eisai Co Ltd has entered into an agreement with Novartis to collaborate on commercial and medical affairs activities (including the provision of scientific evidence to healthcare professionals) for Eisai’s in-house developed novel anticancer agent Lenvima (lenvatinib mesylate) and the anticancer agent everolimus in the US.
Last month, Eisai Inc received approval from the US Food and Drug Administration (FDA) for an additional indication for Lenvima in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. This is the only combination regimen approved in the US to significantly prolong progression-free survival when compared with a standard of care in patients with advanced renal cell carcinoma following prior anti-angiogenic therapy.
Under the terms of the collaboration agreement, Eisai and Novartis sales representatives will promote the availability of this combination regimen to healthcare professionals in the US. The companies will also collaborate on medical affairs activities. Each company will continue to book sales of their respective product.
The number of patients with kidney cancer in the US is estimated to be approximately 58,0001 and renal cell carcinoma comprises more than 90 percent of all malignancies of the kidney. For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this is a disease with significant unmet medical need.
Lenvima is approved for thyroid cancer in over 40 countries including the US, Japan, Europe, South Korea and Canada. Lenvima is also approved in combination with everolimus for patients with advanced renal cell carcinoma in the US. A new drug application seeking approval for an indication covering advanced or metastatic renal cell carcinoma submitted in Europe in January 2016 is under review, and Eisai intends to discuss further steps regarding submission strategies for this potential indication with the regulatory authorities in Japan.
