GMAB - EMA advisory group backs Janssen's Darzalex for AL amyloidosis and multiple myeloma

Genmab (GMAB) announces today that EMA's Committee for Medicinal Products for Human Use ((CHMP)) has adopted a positive opinion and recommended granting marketing authorization for Darzalex SC, in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of adult patients with newly diagnosed systemic light-chain ((AL)) amyloidosis.The opinion was based on data from the Phase 3 ANDROMEDA (AMY3001) study.The CHMP also issued a positive opinion recommending Darzalex SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients multiple myeloma, based on the Phase 3 APOLLO (MMY3013) study.Johnson & Johnson (JNJ) unit Janssen Pharma submitted Type II variation applications to the EMA for these indications in November 2020.Janssen in-licensed global rights for daratumumab from Genmab in August 2012.

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EMA advisory group backs Janssen's Darzalex for AL amyloidosis and multiple myeloma