Genmab’s Darzalex secures CHMP recommendation in Europe for front-line multiple myeloma

pharmafile | December 13, 2019 | News story | Medical Communications, Sales and Marketing CHMP, Genmab, darzalex, pharma 

The Committee for Medicinal Products for Human Use (CHMP), an advisory panel for the European Medicines Agency, has given its recommendation to Genmab’s Darzalex in combination with Bortezomib, Thalidomide and Dexamethasone as a front-line treatment for multiple myeloma (MM) in the European Union.

The indication in question relates to newly diagnosed MM patients who are eligible for autologous stem cell transplant (ASCT).

According to the company, the decision was made on the back of data from the Phase 3 CASSIOPEIA study. While the EMA is not beholden to the recommendation, given its previous decision-making, it is very likely to ultimately make a matching ruling.

“We are very pleased with this positive opinion from the CHMP as, if approved, the combination of Darzalex plus bortezomib, thalidomide and dexamethasone would be the first Darzalex containing regimen that would be a potential treatment option for newly diagnosed patients with multiple myeloma in Europe who are eligible for ASCT,” said Dr Jan van de Winkel, Chief Executive Officer of Genmab.

Matt Fellows

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