Sanofi keeps nipping at J&J's heels as Sarclisa notches new FDA approval in multiple myeloma
The multiple myeloma rivalry between Sanofi and J&J continued Wednesday evening, with the French drugmaker’s Sarclisa taking home a new approval in the indication.
US regulators OK’d the drug in combination with Amgen’s Kyprolis and the steroid dexamethasone for adults with relapsed or refractory multiple myeloma who have received between one and three previous lines of treatment. It’s the second approval for Sarclisa, having previously won a green light in March 2020 as a third-line treatment for the disease.
And with the expanded label now in hand, Sarclisa is once again taking aim at J&J’s market leading Darzalex.
First approved in 2015 for treatment-resistant multiple myeloma, Darzalex quickly became a blockbuster and generated $1.4 billion of sales in its first year. It has since steadily expanded its market, most recently earning an OK last August with the same cocktail and same indication as Sarclisa did Wednesday.
Last year, Darzalex tallied its best year yet with nearly $4.2 billion in sales across all indications, according to J&J and developer Genmab.
Sarclisa, meanwhile, is still finding its footing in the market, having gained its first approval a mere nine days before the WHO declared a global pandemic for Covid-19. The drug pulled in just over $50 million in 2020 sales. But the drug still marked a milestone for Sanofi, as Sarclisa was the French pharma’s first in-house cancer approval since Jevtana in 2010.
Both drugs are monoclonal antibodies that focus on CD38, which is highly expressed on multiple myeloma cells, but function slightly differently. Darzalex locks on to the CD38 molecule, while Sarclisa is engineered to target a specific portion of the antigen found on the protein.
Wednesday’s Sarclisa OK came on the basis of a 302-patient Phase III trial, which showed the combo reduced the risk of disease progression or death by 45% compared to the Kyprolis/dexamethasone standard of care. That clocked in at a p-value of p=0.0032.
Though cross-trial comparisons are never a perfect science, that figure came in numerically higher than the foundation for Darzalex’s approval in the same indication. The Darzalex combo with Kyprolis and dexamethasone only reduced that risk by 37%.
Sarclisa did miss on a secondary endpoint, however, failing to register a statistically significant difference in overall response rate. Those numbers remained similar for each arm: 86.6% for the Sarclisa combo versus 82.9% for standard of care.
Going forward, Sanofi is expecting a decision in this indication from the EU “in the coming months,” and received a positive CHMP opinion in February. Researchers continue to look at Sarclisa across the multiple myeloma landscape as well, as the pharma says it’s engaged in several ongoing Phase III trials. Sanofi is also investigating the drug for the treatment of other hematologic malignancies and solid tumors.