Europe to Expedite Review of RevMed's Cancer Drug

By Rachel Kim

The European Medicines Agency (EMA) has decided to accelerate its review of a cancer drug developed by RevMed, shortening the assessment period from the standard 210 days to 150 days. This decision is part of the EMA's accelerated assessment process, which is applied to drugs deemed to have significant public health benefits or therapeutic innovation.

The accelerated assessment does not influence the final decision on marketing authorization, which is made by the European Commission (EC) following the EMA's Committee for Medicinal Products for Human Use (CHMP) opinion. The EC has up to 67 days to issue a final decision after receiving the CHMP's recommendation.

Historically, nearly half of the cancer drug applications seeking accelerated assessment in the EU have been rejected due to concerns about clinical relevance. Between 2006 and 2014, 12 out of 23 such applications were denied, and some accepted applications reverted to the standard timeline during evaluation.

While the accelerated assessment shortens the review period, it maintains the same rigorous scientific evaluation standards as the standard process. This procedural adjustment aims to facilitate quicker access to potentially life-saving treatments without compromising the thoroughness of the review.