This approval marks the first time in a decade Sanofi has had a wholly-owned cancer drug approved.
The U.S. Food and Drug Administration (FDA) gave the greenlight to Sanofi’s Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for adults with multiple myeloma who have had two previous therapies including lenalidomide and a protease inhibitor. Sarclisa is an intravenous (IV) drug, a CD38-directed cytolytic antibody.
“Today’s FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma,” said Paul Hudson, Sanofi’s chief executive officer. “These are patients whose disease has returned or become resistant to their prior treatment. 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.”
This approval marks the first time in a decade Sanofi has had a wholly-owned cancer drug approved. In a recent interview, Sanofi’s head of development, Dietmar Berger, called it a “return to oncology” for the company, which in recent years has tended to lean on its development partner Regeneron Pharmaceuticals to drive its innovation. The last wholly owned oncology compound the company received approval for was Jevtana in 2010. And Berger said, “Sarclisa is just the first molecule.”
In the company’s ICARIA-MM trial, Sarclisa and pom-dex showed a statistically significant improvement in progression-free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone. That almost doubled the PFS. The trial also demonstrated a significantly better overall response rate compared to pom-dex alone of 60.4% compared to 35.3%.
“Most patients with multiple myeloma unfortunately relapse and become refractory to currently available therapies,” said 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. “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.”
Sanofi indicates that the U.S. list price for Sarclisa is $650 per 100 mg vial and $3,250 per 500 mg vial. This comes, for a typical patient weighing 154 to 176 pounds (70-80 kg), to a cost of $5,200 per infusion. Actual costs will likely be lower because the list price doesn’t reflect insurance, copays or financial assistance from patient support programs.
Multiple myeloma is the second most common hematologic cancer. It affects more than 130,000 people in the U.S., with about 32,000 new diagnoses each year.
“Targeting cells has led to the development of important oncology treatments,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies. In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy.”
