New drug for multiple myeloma closer to EU conditional approval1 Apr 2016
European regulators recommended on April, 1 approving with conditions for Johnson & Johnson's blood cancer drug, saying they would need to evaluate additional data from two ongoing studies. The much awaited drug, called Darzalex or daratumumab, which has already been approved in the United States, offers hope to patients who have run out of options to fight multiple myeloma.
The European Medicines Agency's (EMA) recommendation applies to the use of the antibody treatment in adults who have already undergone standard treatments for multiple myeloma. The EMA grants conditional approval for drugs that fill an unmet medical need for serious conditions and show early evidence of clinical benefits outweighing the risks.
Mechanism of action
J&J's Darzalex, given as an infusion, works by helping the immune system attack cancer cells. Researchers say it is the first antibody shown to be effective against myeloma without being combined with other medicines. European Commission’s final decision is expected in 60 to 90 days. The drug won early approval from the U.S. FDA in November for patients who had already undergone at least three prior standard treatments.
The EMA has asked for additional results from the two ongoing, late-stage studies testing the antibody in combination with standard treatments. Data from both studies will be given by the second half of 2017, the regulator said, adding it would weigh Darzalex's benefits and risks every year until then.Source: Reuters