Merck’s immuno-oncology treatment likely to get FDA’s approval sooner than expected

Merck’s immuno-oncology treatment likely to get FDA’s approval sooner than expected

Merck & Co’s immunotherapy drug, pembrolizumab is likely to be granted approval by the US Food and Drug Administration, as a treatment for melanoma.

With the FDA’s approval, the drug would be the first in a new class of treatments supporting the body’s own immune system to fight cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related PD-L1.

The FDA’s decision is scheduled for October, but sources said the agency could give its approval within weeks, but it is not 100 per cent certain.

Merck has been seeking approval for PD-1 drug application for patients whose skin cancer does not respond to treatment with Yervoy, a Bristol-Myers immunotherapy.

Trials of pembrolizumab have shown that the drug is able to reduce tumours in about a third of patients with late-stage melanoma. According to Dr Antoni Ribas, professor of hematology-oncology at the University of California, Los Angeles, allowing the drug to be sold to melanoma patients would be a significant development, as there are still few options available for them.

Merck and its rivals are also studying PD-1 drugs as a treatment for other types of cancer, such as lung cancer.

The difference between the current cancer treatments and pembrolizumab is that the novel immuno-oncology drugs trigger the body’s own ability to recognize and destroy cancer cells, rather than killing cancer cells directly.

However, some researchers point to a potential risk is that stimulating the immune system could cause side effects, from mild rash to more serious liver problems or colitis.