Bristol-Myers Squibb Announces Multiple Regulatory Milestones for Opdivo (nivolumab)

STAT transcription factor involved in many kinds of cancers. STAT3 is usually in a state of activation in tumor cells, therefore drug targeting effect of STAT3 is often used in cancer treatment. However STAT3 on the development of the immune system is very important. Recently, researchers from Austria public university through the study revealed, blocking the immune system cells in the STAT3 may lead to enhanced efficacy of anti tumor immunity, new cancer therapy which anti STAT3 development offers new hope, related research published in the International Journal of Blood.

This so-called signaling proteins and transcription activator STAT is a key group of many different signal paths, many types of cancer are directly related to STAT protein.STAT3 is a kind of "arch-criminal" common, usually in the activated state of expression in tumor cells, the researchers spent a lot of efforts to effect of STAT3 in the field of target in the development, but still can not determine whether the targeted STAT3 therapy is suitable for the treatment of cancer patients.

At present, the most important problem in Stat3 is a transcription factor essential for healthy individuals play many key functions, especially the development of the immune system is crucial for many immune cells, especially a called natural killer cells, which is the first line of defense to help the body against viruses and cancer invasion. Ability of mouse natural killer cells in the STAT3 decreased will enhance the body against melanoma and leukemia cells, and transfer ability of melanoma cells will decrease, so the researchers said, natural killer cell deletion of STAT3 may be effective "killer tumor cells".

Finally, the researchers noted, loss of STAT3 will promote the natural killer cells become lost vitality, on the contrary it will enhance natural killer cell killing tumor cell potential; the inhibition of STAT3 may help in the treatment of cancer patients through two ways, one of which is a block cancer cell division, another is to enhance natural killer cells of the patients withthe bodytomoreeffectively the end ofcancer cells.

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease, and occurs when cancer spreads beyond the surface of the skin to the other organs, such as the lymph nodes, lungs, brain or other areas of the body.

Melanoma is less common than other skin cancers. However, it is much more dangerous if it is not found in the early stages. It causes the majority (75%) of deaths related to skin cancer. Globally, in 2012, melanoma occurred in 232,000 people and resulted in 55,000 deaths. Australia and New Zealand have the highest rates of melanoma in the world. It has become more common in the last 20 years in areas that are mostly Caucasian.

These days, Bristol-Myers Squibb Company announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor. In the U.S., the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for previously treated advanced melanoma and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is March 30, 2015. The FDA also granted Opdivo Breakthrough Therapy status for this indication. In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for Opdivo in advanced melanoma. The application has also been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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