Sanofi scores FDA approval for Sarclisa combo in relapsed, refractory multiple myeloma

pharmafile | March 3, 2020 | News story | Manufacturing and Production, Sales and Marketing Cancer, Sanofi, Sarclisa, multiple myeloma, pharma 

Sanofi’s monoclonal antibody and CD-38 inhibitor Sarclisa (isatuximab-irfc) has been awarded marketing authorisation from the FDA in the treatment of relapsed, refractory multiple myeloma (RRMM)

The therapy is approved in combination with pomalidomide and dexamethasone (pom-dex) in adult patients who have previously received two prior therapies including lenalidomide and a proteasome inhibitor. According to Sanofi, the therapy will be available “shortly”.

“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,” said Paul Hudson, Sanofi’s Chief Executive Officer. “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 programme in multiple myeloma, as well as in other blood cancers and solid tumours.”

In clinical trials, the Sarclisa combo was shown to extend progression-free survival by a median of 11.53 months, providing a “statistically significant improvement” over the median 6.47 months recorded by pom-dex alone. Additionally, the combo exhibited an overall response rate of 60.4% compared to 35.3% with pom-dex alone.

“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,” explained Dr Paul Richardson, Principal investigator of the trial and Clinical Program Leader and Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.

“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.”

Matt Fellows

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