The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for daratumumab, marketed by Janssen as Darzalex.

If approved by the European Commission, daratumumab can be used in combination with lenalidomide and dexamethasone; or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.

The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed MM patients do not reach five-year survival.

Almost 29% of patients with MM will die within one year of diagnosis.

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.

While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.

Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.

The Positive Opinion of the CHMP was based on a review of data from the Phase III POLLUX study, published in The New England Journal of Medicine in October 2016, and the Phase III CASTOR study, also published in The New England Journal of Medicine in August 2016.

“This Positive Opinion recognises progress in the treatment of multiple myeloma and has the potential to offer new treatment options to eligible patients.” said Torben Plesner, M.D., Vejle Hospital, Vejle, Denmark, a daratumumab clinical trial investigator. “Daratumumab has already demonstrated single-agent efficacy in highly refractory patients. Now, consistent with these data, the results when used in combination with standard-of-care regimens after one prior line of therapy are also encouraging.”

The safety profile of daratumumab in combination with standard-of-care regimens was consistent with monotherapy studies.

In combination with lenalidomide, and dexamethasone (POLLUX) the most common adverse events of grade 3 or 4 during treatment were neutropenia (51.9%), thrombocytopenia (12.7%), and anaemia (12.4%).

 Daratumumab-associated infusion-related reactions occurred in 47.7% of the patients and were mostly of grade 1 or 2.

In combination with bortezomib and dexamethasone (CASTOR) three of the most common grade 3 or 4 adverse events reported were thrombocytopenia (45.3%), anaemia (14.4%), and neutropenia (12.8%).

Infusion- related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of patients), and in 98.2% of these patients, they occurred during the first infusion.

The CHMP’s Positive Opinion will now be reviewed by the European Commission, which has the authority to grant approval of the new indication.

Source: EMA