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