Positive CHMP opinion granted for Amgen relapsed multiple myeloma treatment
The innovative head-to-head Endeavor study of Kyprolis can be combined with dexamethasone. It shows twice as many progression-free survival rates over Velcade (bortezomib) as well as dexamethasone.
The target recipients of these treatments are adult patients who have multiple myeloma. They must have had a minimum of one earlier therapy to qualify for using Kyprolis with dexamethasone.
With the positive opinion of CHMP, the European Commission (EC) will now review the related feedback. If it is approved by the EC, then the marketing authorization will include Kyprolis with dexamethasone for 28 member countries within the European Union, in addition to Lichtenstein, Iceland and Norway.
"In the first-ever comparative phase-three head-to-head study of two proteasome inhibitors in relapsed multiple myeloma, Kyprolis in combination with dexamethasone nearly doubled progression-free survival compared to a current standard of care regimen," Sean Harper, executive vice president of research and development at Amgen, said. "We are pleased that the CHMP has recognized these robust data with a positive opinion, and we look forward to ensuring approval of this extended indication of Kyprolis."