Japan approves Elplat (oxaliplatin) for postoperative adjuvant chemotherapy in gastric cancer- Yakult
Debiopharm International and its partner Yakult has obtained approval in Japan for a supplemental new drug application for Elplat (oxaliplatin) 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.
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