The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly.

The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma.

In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially lifesaving medicines for patients with severe or life-threatening conditions.

For a product to qualify for EAMS, it must be granted a promising innovative medicine (PIM) designation based on early (Phase I and/or II) clinical data and satisfy additional criteria including the severity of the condition the product is intended to treat and the level of improvement over previously authorized treatments.

For more details, go to: http://www.raps.org/Regulatory-Focus/News/2015/06/03/22616/Cancer-Drugs-First-to-Take-Advantage-of-UK-Early-Access-Scheme/