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 Therapy

ONO 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

  1. Melanoma

  2. Non-small cell lung cancer

  3. Advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy

  4. Advanced non-squamous NSCLC with progression on or after platinum-based chemotherapy and with tumors express PD-L1 (IHC PD-L1 expression 5%). Patients with EGFR or

  5. Renal cell carcinoma

  6. Squamous cell carcinoma of the head and neck

  7. Classical Hodgkin lymphoma

  8. Urothelial carcinoma

  9. Unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab

    ALK genomic tumor aberrations should have disease progression after treatment with EGFR or ALK inhibitor.

    Advanced renal cell carcinoma after prior anti-angiogenic therapy

    Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy

    As monotherapy, classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin

    Locally advanced unresectable or metastatic urothelial carcinoma after failure of prior platinum-containing therapy

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 Opdivo

Opdivo 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 Collaboration

In 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.
Distributed by Public, unedited and unaltered, on 07 November 2017 02:03:00 UTC.

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