UK patients given access to Keytruda for advanced melanoma prior to European license

Merck has announced that Keytruda is the first treatment to be accepted through the United Kingdom’s new Early Access to Medicines Scheme.

Early study findings and unmet need were the basis for accepting Keytruda (pembrolizumab), an anti-programmed death receptor-1 (PD-1) therapy, under the Early Access to Medicines Scheme (EAMS), according to a press release from Merck. EAMS was introduced in 2014 by the U.K. Medicines and Healthcare Regulatory Agency (MHRA) to help patients to benefit from promising treatments before a European license has been granted. The Promising Innovative Medicine designation was given to pembrolizumab in October, and the European Marketing Authorization for its treatment of advanced melanoma is currently under review, the release stated.

Review data of KEYNOTE-001, the largest phase 1b study of anti-PD-1 was the basis of the EAMS acceptance, according to the release.

The FDA granted accelerated approval to pembrolizumab for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs in September 2014.

EAMS aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have marketing authorization, yet where there is a clear unmet medical need, the release stated. The MHRA will give a scientific opinion on the benefit/risk balance of the medicine at the time of the EAMS submission, which lasts a year and cannot be renewed. The MHRA opinion does not replace normal licensing procedures and the scheme is voluntary, according to the release.

Severe adverse events reported in patients with advanced melanoma receiving pembrolizumab include pneumonitis, colitis, hepatitis, hypophysitis, nephritis and hyperthyroidism, according to the release. Other adverse events included fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia and diarrhea.

Reference: www.merck.com