First Approval for First PD Inhibitor: Nivolumab for Melanoma

Zosia Chustecka

July 09, 2014

Updated July 9, 2014 — The first immunotherapy product to act on the programmed death (PD) pathway has just been granted its first approval in the world.

Nivolumab has been approved for use in melanoma in Japan as Opdivo (Ono Pharmaceutical). Ono also has rights to the drug in Korea and Taiwan.

The drug is licensed elsewhere to Bristol-Myers Squibb.

This is one of the most highly anticipated drug approvals in oncology — the product has shown unprecedented responses in melanoma, as well as several other tumor types, and the data on this drug have dominated the news coming out of oncology meetings for the last 2 years. It has led to a huge interest in immunotherapy, and manipulation of the PD pathway in particular, and many pharmaceutical companies are investing in this research area, considered to be one of the most promising in the whole cancer field.

The Japanese approval for nivolumab is for use in unresectable melanoma.

Ono said that it will provide the drug free of charge as soon as it is available until the time that it is listed on the national health insurance price list.

Also, because there was a "very limited number" of patients treated with nivolumab in Japanese clinical trials, the company is required to perform a postmarketing use/results survey covering all cases until data on a certain minimum number of patients have been accumulated.

Currently, only the chemotherapy dacarbazine is available as a standard drug therapy for patients with advanced melanoma in Japan, the company noted.

Other Tumor Types

Although the clinical efficacy of nivolumab was first demonstrated in melanoma, it has since shown efficacy in a number of other tumor types, and Bristol-Myers Squibb has numerous studies with the drug ongoing.

In the United States, the US Food and Drug Administration has granted a fast track designation for melanoma, non-small-cell lung cancer, and renal cell carcinoma, and it was recently granted breakthrough therapy designation for the treatment of patients with Hodgkin's lymphoma after failure of autologous stem cell transplant and brentuximab.

Expanding Market for Cancer Immunotherapy

The market for cancer immunotherapy in major world markets is set to grow from a value of $1.1 billion in 2012 to nearly $9.0 billion in 2022, according to a new report from Decision Resources.

The report says the fast growth will be driven by novel immunotherapies that are expected to be launched in the near future. In addition to nivolumab, which has just been approved in Japan, there are a number of drugs with a similar action of inhibiting the programmed cell death pathway, including Merck & Co.'s pembrolizumab (MK-3475), Roche/Genentech/Chugai's MPDL-3280A, and AstraZeneca/MedImmune's MED14736.

Experts interviewed for the report "were considerably optimistic about the potential" of these PD inhibitors, based on promising data released so far in multiple oncology indications, according to the company.

"We anticipate that nivolumab will be the sales-leading agent among immunotherapies. However, it will face direct and intense competition from other PD agents, notably from pembrolizumab in malignant melanoma and non-small-cell lung cancer and, to a lesser extent, from MPDL-3280A in non-small-cell lung cancer," commented Khurram Nawaz, MSc, group senior business insights analyst at Decision Resources.


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