FDA Approves of Darzalex Combination for Multiple Myeloma

The FDA has approved the use of Janssen Biotech, Inc’s immunotherapy Darzalex in combination with pomalidomide and dexamethasone. Darzalex is used to treat multiple myeloma patients who have previously received at least 2 therapies with lenalidomide and a proteasome inhibitor.

In 2015, Darzalex was first approved as a monotherapy treatment for multiple myeloma patients who received at least 3 prior lines of therapy. Then in 2016, the drug received new FDA approvals to treat multiple myeloma patients with at least 1 prior therapy and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone.

"Despite tremendous progress, most patients with multiple myeloma continually relapse or become resistant to available therapies, such as [proteasome inhibitors] and immunomodulatory agents,” Ajai Chari, MD, an associate professor of medicine for the Multiple Myeloma Program and associate director of Clinical Research at Mount Sinai Hospital, said in a statement.

The FDA approved use of Darzalex in combination following the results of the phase 1b EQUULEUS study. The study included 103 multiple myeloma patients who had received a prior proteasome inhibitor and immunomodulatory agent. The participants then received 16 mg/kg of Darzalex with pomalidomide and low-dose dexamethasone. This treatment was continued until the disease progressed.

The data showed that Darzalex combined with pomalidomide and dexamethasone results in an overall response rate of 59.2%, with very good partial response in 28.2% of patients, complete response in 5.8%, stringent complete response in 7.8%, and partial response was achieved in 17.5% of patients.

"The recent approval of Darzalex is significant for patients and clinicians who urgently need new options and regimens,” said Peter F. Lebowitz, MD, PhD, from the Global Oncology Head at Janssen Research & Development, LLC. “This milestone underscores the versatility of Darzalex with a range of treatment regimens. We look forward to continued study of daratumumab in earlier stages of multiple myeloma and other cancers."