The U.S. Food and Drug Administration (FDA) has affirmed Sarclisa® (siltuximab-irfc) in a mix with pomalidomide and dexamethasone (pom-dex) as a treatment for adults with relapsed refractory multiple myeloma (RRMM), who have gotten at any rate two earlier treatments including lenalidomide and a proteasome inhibitor.
Multiple myelomas is a malignant growth that structures in a kind of white blood cell called a plasma cell. Plasma cells assist you with battling diseases by making antibodies that perceive and attack germs.
Multiple myelomas make malignancy cells amass in the bone marrow, where they replace the healthy platelets. As opposed to delivering helpful antibodies, the malignant cells produce abnormal proteins that can lead to complications.
At the point when signs and symptoms become visible, they can include bone pain, particularly in your spine or chest, nausea, constipation, loss of appetite, mental fogginess, disarray, fatigue, frequent diseases, weight loss, weakness in your legs and excessive thirst.
Sarclisa was recently approved by the FDA. It is a “monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.”
According to Paul Hudson, Chief Executive Officer, Sanofi, “Today’s FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma. These are patients whose disease has returned or become resistant to their prior treatments. At Sanofi, we are focused on discovering and developing medicines that may change the practice of medicine, and Sarclisa offers a potential new standard of care in the United States. We continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumors.”
The ICARIA-MM study showed that the combination of Sarclisa with pom-dex was more effective than the former alone. The mixture showed a significant improvement in “progression-free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010).” Further, it also showed a greater response rate as compared to pom-dex alone.
Paul Richardson, principal investigator of ICARIA-MM and clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute said, “Most patients with multiple myeloma, unfortunately, relapse and become refractory to currently available therapies. Sarclisa used in combination with pomalidomide and dexamethasone offers an important new treatment option for patients in the United States living with this incurable disease”.
He further added, “The pivotal ICARIA-MM trial was the first Phase 3 study of a CD38 antibody in combination with pom-dex to present results demonstrating significant clinical benefit in this setting. The study enrolled a broad population of patients with relapsed and refractory multiple myeloma that is particularly difficult to treat and with poor prognosis, which is reflective of real-world practice.”
The treatment was overall effective, however, there were some adverse reactions in some of the patients. The side effects included:
- Infused related reactions
- Upper respiratory tract infection