Debiopharm International SA (Debiopharm) congratulate its partner Yakult’s commitment in obtaining approval for a supplemental new drug application for Elplat® in postoperative adjuvant chemotherapy in gastric cancer, expanding the indications for this product (50mg, 100mg and 200mg).
This supplemental new drug application was approved mainly based on the results of two clinical studies; a Phase III study which was conducted outside Japan to verify the benefits of the combination therapy with Elplat® and an anticancer drug, capecitabine (CLASSIC study), and a Phase II study which was jointly conducted by Yakult Honsha Co., Ltd. and Chugai Pharmaceutical Co., Ltd. in Japan.
Oxaliplatin is the active ingredient of Elplat®, a diaminocyclohexane (DACH) platin. Developed by Debiopharm, it has dramatically changed the prognosis of colorectal as well as pancreatic cancers.
"We strongly believe that Elplat® will provide new treatment options beyond the standard of care in gastric cancer, leading to better outcomes for the patients", stated Thierry Mauvernay, Co-President & Delegate of the Board, Debiopharm Group™.
Gastric cancer is the most common cancer in Japan and the number of newly diagnosed gastric cancer patients during 2011 is estimated at 132,033. Debiopharm is the licensor of Elplat® to Yakult for the development and commercialization in Japan.