#melanoma - first approved treatment on the Programed Death (PD) for melanoma.

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). 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. Because there was a "very limited number" of patients treated with nivolumab in Japanese clinical trials, Ono 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.

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.

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.