Japan Approves Cetuximab Saratolacan in Unresectable Locally Advanced/Recurrent Head & Neck Cancer
By Peter Hofland, Ph.D
September 25, 2020
Japan’s Ministry of Health, Labour and Welfare has approved cetuximab saratolacan sodium (previously known as RM-1929; Akalux® IV Infusion 250mg; Rakuten Medical*) for the apan Approves Cetuximab Saratolacan in Unresectable Locally Advanced/Recurrent Head & Neck Cancer
By Peter Hofland, Ph.D September 25, 2020
Japan’s Ministry of Health, Labour and Welfare has approved cetuximab saratolacan sodium (previously known as RM-1929; Akalux® IV Infusion 250mg; Rakuten Medical*) for the treatment of unresectable locally advanced or recurrent head and neck cancer.
The Ministry of Health also approved Rakuten’s BioBlade® Laser System, the medical device used in the combination with cetuximab saratolacan.
This combination was developed using Rakuten Medical’s Illuminox™ cell-targeting platform, which, in pre-clinical studies has shown to lead to rapid and selective cell killing and tumor necrosis.
The Illuminox platform is based on a cancer therapy called photoimmunotherapy, which was developed by Hisataka Kobayashi, M.D., Ph.D., and a team from the National Cancer Institute (NCI) in the United States.[1] Kobayashi and his team developed a near-infrared (NIR) photoimmunotherapy (PIT), a molecularly targeted phototherapy for cancer that is based on injecting a conjugate of a near-infrared, water-soluble, silicon-phthalocyanine derivative, IRdye700DX (IR700), and cetuximab (Erbitux®; Eli Lilly and Merck Serono), an epidermal growth factor receptor (EGFR) antibody expressed antigen on the cancer cell surface approved for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) and squamous cell cancer of the head and neck (SCCHN).
Regulatory pathway Cetuximab saratolacan received Sakigake Designation** in April 2019, and the application foapan Approves Cetuximab Saratolacan in Unresectable Locally Advanced/Recurrent Head & Neck Cancer By Peter Hofland, Ph.D
September 25, 2020
Japan’s Ministry of Health, Labour and Welfare has approved cetuximab saratolacan sodium (previously known as RM-1929; Akalux® IV Infusion 250mg; Rakuten Medical*) for the treatment of unresectable locally advanced or recurrent head and neck cancer.
The Ministry of Health also approved Rakuten’s BioBlade® Laser System, the medical device used in the combination with cetuximab saratolacan.
This combination was developed using Rakuten Medical’s Illuminox™ cell-targeting platform, which, in pre-clinical studies has shown to lead to rapid and selective cell killing and tumor necrosis.
The Illuminox platform is based on a cancer therapy called photoimmunotherapy, which was developed by Hisataka Kobayashi, M.D., Ph.D., and a team from the National Cancer Institute (NCI) in the United States.[1] Kobayashi and his team developed a near-infrared (NIR) photoimmunotherapy (PIT), a molecularly targeted phototherapy for cancer that is based on injecting a conjugate of a near-infrared, water-soluble, silicon-phthalocyanine derivative, IRdye700DX (IR700), and cetuximab (Erbitux®; Eli Lilly and Merck Serono), an epidermal growth factor receptor (EGFR) antibody expressed antigen on the cancer cell surface approved for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) and squamous cell cancer of the head and neck (SCCHN).
Regulatory pathway Cetuximab saratolacan received Sakigake Designation** in April 2019, and the application for approval under the Conditional Early Approval System was made in March 2020. Outside of Japan, Rakuten Medical does not have the approval of its investigational therapies and is currently running a global Phase III trial.
https://www.oncozine.com/...lly-advanced-recurrent-head-neck-cancer/r approval under the Conditional Early Approval System was made in March 2020. Outside of Japan, Rakuten Medical does not have the approval of its investigational therapies and is currently running a global Phase III trial.
https://www.oncozine.com/...d-recurrent-head-neck-cancer/unresectable locally advanced or recurrent head and neck cancer.
The Ministry of Health also approved Rakuten’s BioBlade® Laser System, the medical device used in the combination with cetuximab saratolacan.
This combination was developed using Rakuten Medical’s Illuminox™ cell-targeting platform, which, in pre-clinical studies has shown to lead to rapid and selective cell killing and tumor necrosis.
The Illuminox platform is based on a cancer therapy called photoimmunotherapy, which was developed by Hisataka Kobayashi, M.D., Ph.D., and a team from the National Cancer Institute (NCI) in the United States.[1] Kobayashi and his team developed a near-infrared (NIR) photoimmunotherapy (PIT), a molecularly targeted phototherapy for cancer that is based on injecting a conjugate of a near-infrared, water-soluble, silicon-phthalocyanine derivative, IRdye700DX (IR700), and cetuximab (Erbitux®; Eli Lilly and Merck Serono), an epidermal growth factor receptor (EGFR) antibody expressed antigen on the cancer cell surface approved for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) and squamous cell cancer of the head and neck (SCCHN).
Regulatory pathway Cetuximab saratolacan received Sakigake Designation** in April 2019, and the application for approval under the Conditional Early Approval System was made in March 2020. Outside of Japan, Rakuten Medical does not have the approval of its investigational therapies and is currently running a global Phase III trial.
https://www.oncozine.com/...ally-advanced-recurrent-head-neck-cancer/ |