Posted by Michael Wonder on 13 Dec 2019
CHMP grants positive opinion for expanded use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are transplant eligible
13 December 2019 - If approved by the European Commission, the daratumumab-VTd regimen would represent the first therapeutic option indicated for newly diagnosed patients who are eligible for a stem cell transplant in six years.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the CHMP of the EMA has recommended broadening the existing marketing authorisation for Darzalex (daratumumab) to include the use of daratumumab in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of adult patients with newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.
The Positive Opinion is supported by data from Part 1 of the Phase 3 CASSIOPEIA (MMY3006) study, published in The Lancet in June 2019, and presented at the 2019 American Society of Clinical Oncology Meeting.
