The U.S. Food and Drug Administration (FDA) is giving priority review to a supplemental Biologics License Application (sBLA) to approve Genmab‘s Darzalex (daratumumab) in combination with Revlimid (lenalidomide) and Decadron (dexamethasone), or with Velcade (bortezomib) and Decadron, to treat multiple myeloma patients who have received at least one prior therapy.
In July, the FDA granted Breakthrough Therapy Designation to Darzalex for the indication, in order to expedite its development and review. In August, Janssen Biotech, Genmab’s licensing partner, submitted the sBLA.
By granting priority review, the FDA will make its decision within six months rather than the standard 10 months. Completion of the FDA review should come by Feb. 17, 2017.
The FDA has also granted a Standard Review period for the use of Darzalex in combination with Pomalyst (pomalidomide) and Decadron for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, with a proteasome inhibitor and an immunomodulatory agent. The action date for the combo treatment is June 17, 2017.
“People suffering from multiple myeloma always ultimately relapse after receiving treatment with the therapies available today. The application for daratumumab in combination with current backbone therapies for patients who have already received at least one type of treatment is a key step towards trying to bring new treatment options to patients with multiple myeloma,” Genmab’s CEO Jan van de Winkel, PhD, said in a press release.
In June, Jansen presented results from the ongoing CASTOR study (NCT02136134) showing that Darzalex, in combination with standard of care Velcade and Decadron, reduced the risk of disease progression or death by 61 percent compared Velcade and Decadron alone, in multiple myeloma patients who received at least two lines of therapy.
A significant improvement in overall response rate was also seen in patients treated with the Darzalex combination compared to those treated with standard care, both in complete response rates (19% versus 9%) and in partial response rates (59% versus 29%). A final progression-free survival (PFS) endpoint has not been reached. The trial is expected to conclude in March 2017.
In May 2016, Genmab revealed interim results from the ongoing POLLUX study (NCT02076009), showing a 63 percent reduction in risk of disease progression in relapsed or refractory multiple myeloma patients receiving the Darxalex in combination with Revlimid and Decadron, compared to patients on Revlimid and Decadron alone. In the trial, patients treated with Revlimid and Decadron had a median PFS of 18.4 months, while PFS of the Darxalex group had not yet been reached. The trial is expected to conclude in May 2017.
The sBLA submission also included data from an open-label, Phase 1b study (NCT01998971) of Darzalex in combination with Pomalyst and Decadron in relapsed and refractory multiple myeloma patients who had been previously treated with at least two lines of therapy.