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Nivolumab Receives Manufacturing and Marketing Approval in Japan for the Treatment of Unresectable Melanoma

Nivolumab, the world’s first approved PD-1 targeting immunotherapeutics
10 Jul 2014
Melanoma and other skin tumours;  Cancer Immunology and Immunotherapy

On 4th July, 2014 the Ono Pharmaceutical Co., Ltd. from Osaka, Japan announced that has received manufacturing and marketing approval for the anti-PD-1 monoclonal antibody nivolumab (OPDIVO®) for the treatment of unresectable melanoma. In Japan, there has been an unmet need for an effective treatment of patients with advanced melanoma and currently, only dacarbazine monotherapy is available as standard drug therapy.

Nivolumab is an anti-PD-1 monoclonal antibody. By blocking PD-1-mediated negative regulation of lymphocytes (e.g. the interaction of PD-1 with its ligands PD-L1 and PD-L2), it thereby enhances the ability of the immune system to recognise cancer cells as foreign and eliminate them.

To help patients who need early treatment with nivolumab, based on ethical considerations, the company will provide access to drug free of charge as soon as it is ready. This program will be offered until the product is listed on the Japanese national health insurance price list and at some limited medical institutions where phase II clinical trials of nivolumab were performed and those are prepared to accept the drug access program.

The recommended dose for adults is 2 mg/kg of nivolumab administered as an intravenous infusion every 3 weeks.

Conditions for approval

Because of the very limited number of patients treated with nivolumab in Japanese clinical trials, the company is required to perform a post-marketing use-results survey covering all cases until data on a certain minimum number of patients have been accumulated. Through these activities, the company should identify the characteristics of patients to be treated with drug and collect safety and efficacy data as soon as possible, thereby taking actions necessary to ensure the proper use of drug.

Anti-PD-1 inhibitors receive a lot excitement among oncologists

Nivolumab is anti-PD-1 monoclonal antibody generated under a research collaboration entered into effect in May 2005 between ONO and the USA-based company Medarex, Inc. When Medarex, Inc. was acquired by Bristol-Myers Squibb Company in 2009, it also granted rights to Bristol-Myers Squibb to develop and commercialise the drug in North America. Through the collaboration agreement entered into effect in September 2011 between ONO and Bristol-Myers Squibb, ONO granted exclusive rights to Bristol-Myers Squibb to develop and commercialise nivolumab in the rest of the world, except in Japan, Korea and Taiwan where ONO has retained all rights to develop and commercialise the compound.

On 24 June 2014, Bristol-Myers Squibb Company announced that a randomised blinded comparative phase III study evaluating nivolumab versus dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the Independent Data Monitoring Committee showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm. Patients in the trial will be unblinded and allowed to cross over to nivolumab.

Nivolumab is being also studied in trials for other tumour types, notably for non-small cell lung cancer. In April this year nivolumab was filed in the USA for melanoma.

On 30 June 2014, Merck announced the European Medicines Agency has accepted for review a Marketing Authorisation Application for pembrolizumab (MK-3475), the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.

Last update: 10 Jul 2014

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