1 April 2016 - The EMA has recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of adults with relapsed and refractory multiple myeloma. Darzalex is to be used in patients whose previous treatment included a proteasome inhibitor and an immunomodulatory agent (other types of cancer medicines) and whose disease worsened after treatment.

Darzalex is a monoclonal antibody that works by activating the body’s immune system to attack and kill multiple myeloma cells.

The CHMP reviewed Darzalex under EMA’s accelerated assessment program and recommended conditional approval for the medicine. These are two of the Agency’s main mechanisms to facilitate early access to medicines that fulfill unmet medical need. Conditional approval allows EMA to recommend a medicine for marketing authorisation in the interest of public health where the benefit of its immediate availability to patients outweighs the risk inherent in the fact that additional data are still required.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/04/news_detail_002503.jsp&mid=WC0b01ac058004d5c1