Janssen’s Darzalex (daratumumab) received full approval by the European Commission (EC) for use in treating adult patients with multiple myeloma who have received at least one prior therapy. The EC approved Darzalex for use not only as a single therapy, but in combination with Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone.
“This approval is an important step for people living with multiple myeloma across our region and offers some patients a new treatment option. We are encouraged by the data we have seen for daratumumab [Darzalex] to date and will continue to investigate its potential,” Catherine Taylor, Hematology Therapeutic Area Lead, Janssen Europe, Middle East and Africa, said in a press release.
Provisional approval, granted by the EC in May 2016, only considered the use of Darzalex as a standalone therapy for treatment of adult patients with relapsed and refractory multiple myeloma. Approval was limited to patients whose disease had progressed while using a prior therapy that included a proteasome inhibitor, such as Ninlaro (ixazomib), and an immunomodulatory agent, such as Revlimid or dexamethasone.
The EC’s full approval was based on results from the Phase 3 POLLUX study (NCT02076009) and Phase 3 CASTOR study (NCT02136134). Their findings were published in The New England Journal of Medicine, in two articles titled “Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma” and “Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma.”
Results from these trials showed that adding Darzalex to standard of care regimens improved response in patients with multiple myeloma. Darzalex significantly reduced the risk of disease progression or death by 63 percent in the POLLUX study and 61 percent in the CASTOR study.
In addition, the safety profile of Darzalex in combination with standard therapies was consistent with those previously reported for Darzalex as a single therapy. In combination with Revlimid and dexamethasone, the most common therapy-induced adverse events were reduced numbers of immune cells called neutrophils (51.9 percent), reduced levels of platelets in the blood (12.7 percent), and anemia (12.4 percent). Some reactions to the drug delivery method or immediate drug reaction were also reported in 4.7 percent of the patients, but all with low to mild severity.
The most common adverse events reported when using Darzalex in combination with Velcade and dexamethasone were similar, including reduced levels of platelets (45.3 percent), anemia (14.4 percent), and reduced numbers of neutrophils (12.8 percent). Also, infusion-related reactions were reported in 45.3 percent of patients.
Darzalex, in the same combination in multiple myeloma patients whose disease had progressed after a prior treatment, was approved by the U.S. Food and Drug Administration in November 2016.
“Data from both the CASTOR and POLLUX studies demonstrated improved progression-free survival and a reduction in disease progression or death compared to standard of care,” said Torben Plesner, a daratumumab clinical trial investigator from the Vejle Hospital, Denmark. “Together, these results show daratumumab in combination with either a proteasome inhibitor or an immunomodulatory agent, has the potential to provide clinical benefit to patients after one or more lines of therapy.”