Bristol-Myers Squibb Company – The approval of Bristol-Myers Squibb’s Opdivo has been recommended by European regulators. Opdivo, which is a PD-1 immune checkpoint inhibitor, becomes the first of a carefully watched group of immune system-boosting cancer medicines to go be sold in Europe.
Bristol’s Opdivo also known as nivolumab is one of the extremely promising new the green light to use Opdivo for treatment of melanoma. Initially, it had only been approved for melanoma and lung cancer in the United States.
“CHMP’s positive opinion has been received with excitement. It will help in bringing this medicine to those patients in Europe with advanced melanoma and are probably in need of new options,” Michael Giordano, who is the senior vice president, said.
This is the first approval that is being granted by Food and Drug Administration (FDA). Other approvals that were recommended by the Agency included Daiichi Sankyo’s Lixiana, for stroke prevention and Vanda Pharma’s Hetlioz that treats a sleep-wake disorder in blind people.
Bristol-Myers Squibb, which has a broad, global development program, is competing with Merck & Co’s Keytruda, which is only in the United States. However, Keytruda is still waiting for regulatory approval in Europe.
In an effort to expand its territorial rights, Bristol-Myers Squibb got into a collaboration agreement with Ono Pharmaceutical, to develop and commercialize Opdivo globally. So far, its goal is to change survival expectations in cancer patients.
Melanoma is the most aggressive type of skin cancer. It is identifiable through uncontrolled growth of pigment-producing cells (melanocytes) that are usually located in the skin. MA said that Opdivo was recommended for use on its own for the treatment of this illness.
An estimated 232,130 melanoma cases were diagnosed globally in 2012. Reports have it that the incidence of melanoma has been increasing for at least 30 years with an average survival rate of six months.