Posted by Michael Wonder on 02 Dec 2016
CADTH publishes final outcome for Darzalex (daratumumab)
1 December 2016 - The outcome relates to the use of daratumumab for the treatment of patients with multiple myeloma.
The pERC has rejected the submission for Darzalex for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or have failed or are intolerant to a PI and who have failed or are intolerant to an IMiD on the basis that there is insufficient evidence to indicate that it is associated with a net clinical benefit over current treatment alternatives.
Whilst the submission was supported by less than ideal evidence (a single arm phase 2 study and a phase 1/2 open label study), patients with multiple myeloma who have failed three or more lines of treatment do not have many viable treatment options left.
