Rakuten Medical Japan Announces Marketing Approval of Akalux® IV Infusion 250mg and BioBlade® Laser System from the Ministry of Labour, Health and Welfare in Japan for Locoregional Cancer Treatment

On September 25, 2020 Rakuten Medical Inc. reported that its wholly owned subsidiary Rakuten Medical Japan K.K. has received marketing approval in Japan from the Ministry of Health, Labour and Welfare for Akalux IV Infusion 250mg (cetuximab saratolacan sodium) to treat unresectable locally advanced or recurrent head and neck cancer. BioBlade Laser System, the medical device used in the combination with Akalux, was also approved on September 2nd. This combination was developed under the Rakuten Medical Illuminox platform. Akalux received Sakigake Designation in April 2019, and application for approval under the Conditional Early Approval System was made in March 2020. Outside of Japan, Rakuten Medical does not have approval of its investigational therapies and is currently running a global Phase 3 trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Hiroshi Mikitani, Representative Director and Chairman of Rakuten Medical Japan K.K. commented, "In my search for a treatment for my father who was diagnosed with cancer, I encountered a treatment developed by a Japanese researcher. Now, we are moving forth to deliver this treatment to patients fighting with cancer, as soon as possible. Today, we are deeply moved to receive approval in Japan ahead of the world. However, this is just the beginning of Rakuten Medical’s mission. We are dedicated to contribute to cancer treatment and improving the quality of life of as many patients as possible around the world. By bringing everyone together, we will continue to aspire to achieve our corporate mission ‘to conquer cancer.’" (Press release, Rakuten Medical, SEP 25, 2020, View Source [SID1234567624])