by Blood Cancer United
Washington — The U.S. Food and Drug Administration yesterday approved daratumumab and hyaluronidase-fihj (Darzalex Faspro®) for adults with high-risk smoldering multiple myeloma.
In a clinical trial, the drug reduced the risk of progression to active multiple myeloma by 51% compared to active monitoring.
“For the first time, we have a treatment designed to treat an earlier stage of disease before it turns into active blood cancer,” says Lore Gruenbaum, Ph.D., Blood Cancer United® Chief Scientific Officer. “This is a big advance for people with high-risk smoldering multiple myeloma, which until now could only be managed by active monitoring until it progressed to active disease—a strategy called ‘watch and wait’.”
The new treatment is approved only for patients whose smoldering multiple myeloma is categorized as high-risk. There are specific tests and criteria to determine risk level. Patients are encouraged to talk with their cancer team to understand their condition and whether the new treatment is right for them.
Like most drugs that treat serious diseases, daratumumab and hyaluronidase-fihj can cause serious side effects for some, explained Dr. Gruenbaum.
“The best advice in cancer treatment is always to talk to your oncology healthcare team about your individual situation and what’s right for you.”
Follow up is still ongoing, but at the five-year mark, more than half of patients (61.1%) treated with daratumumab and hyaluronidase-fihj had not progressed to the full-blown cancer multiple myeloma compared to 40.7% in the active monitoring group.