publication date: Jun. 16, 2017

Drugs and Targets

FDA approves Darzalex as combination therapy for multiple myeloma

FDA approved the immunotherapy Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Clinical trial results showed an overall response rate of 59.2% with Darzalex in combination with pomalidomide and dexamethasone in these patients. This new indication for Darzalex is supported by data from the phase Ib EQUULEUS study, which showed that the combination of Darzalex with pomalidomide and dexamethasone resulted in an ORR of 59.2% (95% CI: 49.1, 68.8), with very good partial response achieved in 28.2% of patients.

Complete response was achieved in 5.8% of patients; stringent CR was achieved in 7.8% of patients; and partial response was achieved in 17.5% of patients. The median time to response was one month (range: 0.9 to 2.8 months), and the median duration of response was 13.6 months (range: 0.9+ to 14.6+ months).

Darzalex is the first CD38-directed antibody approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. It received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Overall, the safety of the Darzalex combination therapy was consistent with the known safety profiles of Darzalex monotherapy and pomalidomide plus dexamethasone, respectively.

The phase Ib EQUULEUS study included 103 patients with multiple myeloma who had received a prior PI and an … Continue reading FDA approves Darzalex as combination therapy for multiple myeloma

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