Merck's PD-1 Inhibitor May be Approved Earlier Than Anticipated

Pembrolizumab was expected to be approved by October, but the turnaround might be much earlier.

U.S. regulators are likely to approve Merck & Co's highly anticipated immuno-oncology drug, pembrolizumab, as a treatment for melanoma well ahead of a late October deadline, according to three sources familiar with the situation.

If approved by the Food and Drug Administration, the drug would be the first in a promising new class designed to help the body's own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells.

Companies including Bristol-Myers Squibb, Roche Holding AG and AstraZeneca Plc are racing to develop similar treatments for a variety of cancers. Some analysts expect the new class could generate more than $30 billion in annual sales worldwide by 2025.

The FDA is slated to decide on New Jersey-based Merck's application no later than October 28, but sources said the agency could give its approval within coming weeks. The sources, who spoke on condition of anonymity because they were not authorized to discuss the FDA's plans, also acknowledged that the early approval was not guaranteed.

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Source: Reuters