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.

Recommended For You
FDA Approvals, News & UpdatesNewsworthyWeb Exclusives
FDA and CDC Investigate Outbreak of Vaping-Related Illness
In the past week, the US Food and Drug Administration (FDA) has released 2 public announcements related to the use of vaping products.
FDA Approvals, News & UpdatesLymphoma
Polivy a New Targeted Immunotherapy Approved for Patients with B-Cell Lymphoma
In June 2019, the FDA approved a new type of immunotherapy called Polivy, for use in combination with other drugs, in patients with previously treated diffuse large B-cell lymphoma (DLBCL), offering new options for patients whose cancer has returned.
Last modified: August 28, 2019

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.