Sanofi myeloma drug, a competitor to J&J, wins FDA approval

The FDA approved Sarclisa, a CD38-targeting monoclonal antibody. The drug will face stiff competition from J&J’s Darzalex, which has the same antigen target and is approved for the same population of patients.

Text FDA Approved appearing behind ripped brown paper.

A monoclonal antibody that has become a backbone treatment for multiple myeloma has a new competitor.

The Food and Drug Administration said Monday that it had approved Paris-based Sanofi’s Sarclisa (isatuximab-irfc), combined with Bristol-Myers Squibb’s Pomalyst (pomalidomide) and the steroid dexamethasone, for treating multiple myeloma in patients who have received at least two prior therapies that include BMS’ Revlimid (lenalidomide) and a proteasome inhibitor.

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Sarclisa targets CD38, a protein commonly expressed on the surfaces of cancerous cells in multiple myeloma, which is the second most common blood cancer. It’s the same target as Johnson & Johnson’s Darzalex (daratumumab), which was originally approved in 2015 and has since won approval in multiple lines of therapy, including in combination with Pomalyst and dexamethasone in patients who have received two prior therapies that include Revlimid and dexamethasone. Darzalex is also approved in combination with Revlimid for patients with first-line disease.

“While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments for patients with multiple myeloma who have progressive disease after previous therapies,” said Richard Pazdur, acting director of the FDA’s Office of Oncologic Diseases, in a statement.

Sanofi filed for approval for the drug last year, having presented positive data from the Phase III ICARIA-MM study at the American Society of Clinical Oncology’s 2019 annual meeting. The data showed that patients receiving Sarclisa with Pomalyst and dexamethasone had a median progression-free survival of 11.5 months, compared with 6.5 months among those receiving Pomalyst and dexamethasone alone.

For the moment, both Sarclisa and Darzalex are approved for intravenous injection over the course of multiple hours. J&J has applied for FDA approval of a subcutaneous formulation of Darzalex that can be administered in a fraction of the time, thereby giving it a potential competitive edge against Sarclisa. However, an expert said at the ASCO meeting last year that an advantage for Sarclisa is that unlike Darzalex, it is not associated with complement activation, meaning it can be more readily given in patients with asthma or chronic obstructive pulmonary disease.

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