November 7, 2017
Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Expanded Use in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated with Platinum-based TherapyONO PHARMACEUTICAL CO., LTD. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") announced that ONO PHARMA TAIWAN CO., LTD. ("OPTW") received the supplemental approval of Opdivo® Intravenous Infusion 20 mg, 100 mg (Generic name: nivolumab; "Opdivo"), a human anti-human PD-1 (programmed cell death-1) monoclonal antibody, on November 2 from the Taiwan Food and Drug Administration (TFDA) in Taiwan, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
Squamous cell carcinoma of the head and neck (SCCHN) is a general term describing malignant tumors occurring in the head and neck regions, with an estimated about 8,500 affected patients* with SCCHN (excluding cancer of the thyroid gland) annually in Taiwan. While Opdivo was approved for the treatment of patients with "recurrent or metastatic SCCHN with disease progression on or after platinum-based therapy and tumor express PD-L1 (IHC
PD-L1 expression ≧1%)", this approval allows Opdivo to be used for the treatment of the
patient regardless of the tumor PD-L1 expression level.
OPTW is committed to taking measures necessary for proper use of Opdivo by collecting clinical data on the safety and efficacy of Opdivo, so that it can be properly used. In Taiwan, OPTW continues to market Opdivo under the co-promotion with Bristol-Myers Squibb (Taiwan) Ltd., based on the strategic collaboration agreement made between ONO and Bristol-Myers Squibb in July 2014.
*: Cancer Registry Annual Report, 2014 TAIWAN
Outline of Opdivo® Intravenous Infusion 20 mg, 100 mg
Product name | Opdivo® Intravenous Infusion 20 mg, 100 mg |
Generic name (INN) | Nivolumab (recombinant) |
Indication |
|
Dosage and administration | As monotherapy: Usually, for adults, infuse intravenously at 3 mg/kg (body weight) of nivolumab over 60 minutes every 2 weeks. In combination with ipilimumab (melanoma): Infuse intravenously at 1 mg/kg (body weight) of nivolumab over 60 minutes, followed by intravenous infusion on the same day, every 3 weeks for the first 4 doses. Thereafter, infuse intravenously at 3 mg/kg (body weight) of nivolumab over 60 minutes every 2 weeks. |
Approval date | November 2, 2017 |
Manufacturer | Ono Pharmaceutical Co., Ltd. |
Importer/distributor | Ono Pharma Taiwan Co., Ltd.、 |
Distribution collaboration | Bristol-Myers Squibb (Taiwan) Ltd. |
* Underlined part shows the revised one according to this approval
About Ono Pharma Taiwan Co., Ltd.Ono Pharma Taiwan Co., Ltd. (OPTW), in Taipei, Taiwan, was established as an ONO's wholly-owned subsidiary in December 2014. OPTW has started to market specialty products such as anti-cancer agents, including Opdivo. OPTW is committed to distributing and bringing its products developed internally for further penetration into the Taiwanese market.
About OpdivoOpdivo is an immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands.
In Japan, ONO launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable, advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell cancer in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, and unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017. In addition, ONO is conducting clinical development program including esophageal cancer, esophago-gastric junction cancer, small cell lung cancer, hepatocellular carcinoma, glioblastoma, urothelial cancer, malignant pleural mesothelioma, ovarian cancer, biliary tract cancer, etc. Opdivo is currently approved in more than 60 countries including Japan, South Korea, Taiwan, the US and European Union.
About the Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb CollaborationIn 2011, through a collaboration agreement with Bristol-Myers Squibb (BMS), Ono Pharmaceutical Co., Ltd. (ONO) granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where ONO had retained all rights to Opdivo except the US at the time. In July 2014, ONO and BMS further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies - as single agent and combination regimens - for patients with cancer in Japan, South Korea and Taiwan.
Contact
ONO PHARMACEUTICAL CO., LTD.
Corporate Communications public_relations@ono.co.jp
ONO Pharmaceutical Co. Ltd. published this content on 07 November 2017 and is solely responsible for the information contained herein.
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