Sanofi's Sarclisa gains expanded US approval for multiple myeloma

The FDA has approved Sanofi's Sarclisa (isatuximab-irfc) in combination with Amgen's Kyprolis (carfilzomib) plus dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, the company announced. The CD38-directed antibody was initially cleared in the US as well as the EU last year for use in combination with Bristol Myers Squibb's Pomalyst (pomalidomide) and dexamethasone for patients who had received at least two prior therapies.

The latest decision is based on data from the Phase III IKEMA trial, demonstrating that Sarclisa added to Kyprolis and dexamethasone reduced the risk of disease progression or death by 45% compared to Kyprolis and dexamethasone alone. Sanofi reported no statistically significant difference on the secondary goal of overall response rate, which remained similar for each arm at 86.6% for Sarclisa combination therapy versus 82.9% for Kyprolis and dexamethasone alone.

Peter Adamson, global development head for oncology innovation at Sanofi, said that "with this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse."

Competitive pressure on J&J's Darzalex

The new approval could put more competitive pressure on Johnson & Johnson's multiple myeloma drug Darzalex (daratumumab) as Sanofi looks to reinforce Sarclisa's potential as a standard of care. Darzalex was originally cleared in 2015 to treat multiple myeloma in the fourth-line setting, and has had its label expanded several times since, including last year when it became the first CD38 antibody to be approved for use in combination with Kyprolis. Johnson & Johnson's drug generated sales of $1.3 billion in the fourth quarter of 2020.

Meanwhile, in late February, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the combination of Sarclisa with Kyprolis and dexamethasone to treat relapsed or refractory multiple myeloma patients who have received at least one prior therapy. Sanofi said at the time that a final decision was expected "in the coming months."

According to the company, Sarclisa continues to be evaluated in multiple ongoing Phase III trials for multiple myeloma, and is also being investigated as a potential treatment of other haematological malignancies and solid tumours.

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