J&J and Sanofi's multiple myeloma tit-for-tat continues, as subcutaneous Darzalex wins combo approval
J&J and Sanofi have gone back and forth in their multiple myeloma tug-of-war. Earlier this year, Sanofi notched an approval of Sarclisa in combination with Amgen’s Kyprolis to try to outflank the big conglomerate, but J&J is clapping back.
Wednesday afternoon, Amgen announced that the subcutaneous version of J&J’s blockbuster Darzalex is also now approved as a combo with Kyprolis and dexamethasone. The green light came through for adults with relapsed or refractory multiple myeloma who had progressed on one to three earlier lines of therapy.
Amgen execs praised the decision, with R&D chief David Reese saying in a statement the alternative Darzalex administration “will offer increased flexibility and convenience for patients.”
The FDA decision comes after the IV formulation of Darzalex initially clinched approval with Kyprolis back in August 2020. That OK came as Sarclisa had just won an approval the preceding March in third-line multiple myeloma patients.
Though Sarclisa has a long way to go to eclipse Darzalex on the market, it managed to secure the same Kyprolis combo green light in April 2021 — Sarclisa plus Kyprolis plus dexamethasone in patients who progressed on one to three treatments. The back-and-forth between the two drugs will likely continue as Sanofi looks to carve out more of the market.
Should it prove successful, there’s quite a slice of pie to be had. The IV form of Darzalex initially launched in 2015 and quickly became one of J&J’s top sellers with $1.4 billion in sales its first year. And in 2020, the drug tallied its best sales year yet with $4.2 billion.
J&J reports sales together for both forms of the drug — the IV form and the subcutaneous version dubbed Darzalex Faspro.
Sarclisa has not seen as sharp an uptake, as the drug was first approved about a week and a half before the WHO declared a global pandemic last year, limiting patient access. Nonetheless, it marked a milestone for Sanofi, becoming the company’s first in-house cancer approval since 2010.