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FDA Approvals, News & UpdatesMultiple Myeloma

Darzalex-Based Regimen Approved as First Treatment in Patients with Multiple Myeloma Ineligible for Transplant

August 2019 Vol 5 No 4

In June 2019, the FDA approved Darzalex (daratumumab; from Janssen) in combination with Revlimid (lenalidomide; from Celgene) and dexamethasone as the first treatment in patients with multiple myeloma who cannot undergo a stem-cell ­transplant. Darzalex was previously approved for different uses in patients with multiple myeloma.

This latest approval was based on a clinical trial of patients with newly diagnosed multiple myeloma who were not candidates for chemotherapy and a transplant.

Adding Darzalex to the Revlimid plus dexamethasone regimen prolonged the time without disease progression compared with Revlimid plus dexamethasone alone. At the time of the analysis, the average time to disease progression was not reached in patients who received Darzalex (meaning their cancer continues to respond to therapy), but in patients who did not receive Darzalex, the average time to disease progression was 31.9 months.

Adding Darzalex also led to more patients achieving complete response (no sign of cancer) than patients who received only Revlimid and dexamethasone.

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Last modified: August 28, 2019

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