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EMA gives positive opinion on Genmab's Darzalex in combination treatment

On Friday, Genmab came one step closer to receiving EU approval for a rare blood disorder.

Photo: Joost Melis / Genmab / PR

The European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends that Genmab's Darzalex be authorized for use in combination with cancer treatment Velcade and drugs cyclophosphamide and dexamethasone for treating adults with systemic light-chain (AL) amyloidose.

This recommendation encompasses the injection-based version of Darzalex which is marketed as Darzalex SC in the EU and as Darzalex Faspro on other markets, according to a Genmab press release on Friday afternoon.

Aside from the treatment of AL amyloidosis, the CHMP also recommends that Darzalex SC is used in combination with celgene's imnovid and dexamenthason for treating patients with multiple myeloma who have received at least one prior therapy containing a proteasome inhibitor (PI) and lenalidomide, or who have demonstrated disease progression in spite of having received at least two prior therapies that included lenalidomide and a proteasome inhibitor (PI).

Formally, the application for EU marketing authorization was submitted by Genmab's official partner Janssen.

Genmab CEO on legal fight with Janssen: Standing up straight and fighting for what's morally and ethically right 

Analysts to home in on expenses in Genmab's Wednesday fiscal report 

Janssen had better Darzalex sales than expected in Q1 

Genmab CEO on possible settlement in dispute with Janssen: "I have no comment" 

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