Highly anticipated immuno-oncology drug, pembrolizumab, which has shown promising results in trials as a treatment for Melanoma could be approved by the US FDA. The drug is a product from Merck & Co’s, and is being hailed as a treatment for melanoma.
If the drug is approved it will become the first from a promising class of drug which have been designed to fend off cancer by blocking a protein Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to dodge disease-fighting cells.
It is also called Mk – 3475 and belongs to the same class as Bristol Myer Squibb’s Nivolumab. Both the drugs are undergoing clinical trials. The drug is going to be soon available in Japan (Nivolumab).
The drug is being manufactured by Bristol-Myers Squibb, Roche Holding AG and AstraZeneca Plc, who are racing to create similar treatments for different types of cancers. The new class of drugs is expected to be worth $30 billion in annual sales worldwide by 2025 and this is one of the reasons for big multinationals who are investing billions of dollars in research.
The US FDA is expected to take a decision by October 28 on the Merck’s application. However sources are hinting that approval for the new drug could happen within the coming weeks. The sources spoke on conditions of anonymity since they are not authorized to speak to the press. There is also a possibility that FDA delays the approval. A spokeswoman for the FDA said that they could not reveal the status of the applications.
Merck will be promoting the drug in treating melanoma which is not responding to conventional treatment which uses Yervoy, a Bristol-Myers immunotherapy that targets a different part of the immune system. Studies have also revealed that pembrolizumab contract tumors in about a third of patients with late-stage melanoma. More than 10,000 Americans succumb to melanoma each year.
Dr Steven O’Day, director of the Los Angeles Skin Cancer Institute said, “My hope is that over the next five to 10 years, we will be curing over half of melanoma patients.”