EU Recommends Conditional Approval For Johnson & Johnson's Blood Cancer Drug Darzalex


Health regulators in Europe issued on April 1 a recommendation to approve Johnson & Johnson's blood cancer drug, albeit with several conditions.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) said it would need to evaluate additional data about the blood cancer drug from two ongoing studies.

The drug in question is called Darzalex (daratumumab) and is already approved in the United States. Experts say Darzalex offers hope to patients who have run out of options for multiple myeloma treatments.

The EMA gives conditional approval for drugs that provide an unmet medical need for severe conditions and reveal early evidence of benefits outweighing the risks.

The recommendation applies to the use of the treatment in adults who have already went through standard treatments for multiple myeloma, which is a form of cancer that targets infection-fighting plasma cells in the bone marrow.

In 2012, an estimated 39,000 people suffered from this condition in the European Union, EMA said. Only half of patients with multiple myeloma are alive after five years as they develop resistance to therapies. This blood cancer can result to complications such as infections, kidney dysfunction and fractures.

Darzalex is given as an infusion. It works by supporting the immune system to attack cancer cells. Darzalex is also the first antibody treatment shown to be effectual against myeloma without being combined with other drugs.

Existing therapies for multiple myeloma include Revlimid from Celgene Corp., Velcade from Takeda Pharmaceutical Co Ltd., and newer drugs such as Celgene's Pomalyst and Amgen Inc's Kyprolis.

American pharmaceutical Janssen, a unit of Johnson & Johnson's, licensed Darzalex from Danish company Genmab under an exclusive deal in 2012.

Genmab CEO Jan van de Winkel said the CHMP's recommendation brings the drug one step closer toward a fundamentally new treatment option for multiple myeloma patients.

"We look forward to the decision of the European Commission," said van de Winkel.

The Danish biotech company has said separately that it anticipated a final decision from the European Commission within a month or two.

In November, Darzalex won approval in the U.S. from the Food and Drug Administration for patients who have undergone at least three standard treatments.

Meanwhile, data from the two studies -- which EMA is still waiting for -- will be given by late 2017.

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