With the FDA nod for new multiple myeloma med Sarclisa, Sanofi has scored its first approval for a wholly owned oncology medicine in a decade.
Sarclisa won approval to treat adults with relapsed refractory multiple myeloma who’ve received at least two prior therapies. The med is dosed every week for the first four weeks and then every other week until a patient's disease progresses or they can no longer take the medicine. It will cost about $5,200 per infusion, a spokesman said.
In a pivotal study in the approved patient group, Sarclisa plus a standard-of care regimen of Bristol-Myers Squibb's Pomalyst and steroid dexamethasone (pom-dex) reduced the risk of disease progression or death by 40% compared with pom-dex alone.
The drug represents a “return to oncology” for Sanofi, head of development Dietmar Berger said in an interview. The company previously developed drugs such as Taxotere and other chemotherapy medicines, but it hadn’t scored approval for a wholly owned oncology molecule since Jevtana in 2010.
These days, the company is “clearly refocused” in hematology and oncology, Berger said, and it's advancing an internal pipeline as well as reviewing external options. Sanofi recently picked up Synthorx for its candidates in oncology and immunology.
“Sarclisa is just the first molecule," Berger said.
There are about 130,000 multiple myeloma patients in the U.S., and 32,000 new patients are diagnosed each year, Berger said. The patients cycle through different types of therapies, and researchers are continuously working to make better drugs at each line.
Sanofi has ongoing studies for Sarclisa—which the FDA approved well ahead of its April 30 action date—in second- and first-line uses and aims to treat the “whole spectrum of disease," Berger said. The drugmaker is also testing the med, both alone and in combinations, in other hematologic malignancies and solid tumors.
At an investor day back in December, Sanofi presented (p. 85) a cross-trial comparison of the drug’s phase 3 trial, Icaria, compared with trials for Johnson & Johnson’s Darzalex and Bristol-Myers Squibb’s Empliciti. The trials didn’t compare the meds directly against one another, but Sarclisa’s progression-free survival figure topped the other drugs' in their individual trials, according to the presentation.
Sanofi estimates the total third-line market opportunity in the U.S. and major European markets at $3.4 billion. The second-line market estimate is bigger, at $6 billion.
Under new CEO Paul Hudson, Sanofi has backed away from R&D in its struggling diabetes and cardiovascular areas and doubled down in rare diseases and other areas in which it believes it can succeed. One drug getting a lot of attention is the Regeneron-partnered Dupixent, which Hudson figures can become a €10 billion-per-year medicine at peak.