- The Food and Drug Administration on Monday approved a new drug for multiple myeloma, clearing Sanofi's Sarclisa for market at a time when drugmakers are racing to develop new types of therapies for the blood cancer.
- Sarclisa, which targets a protein found on the surface of myeloma cells, is the first cancer treatment wholly owned by Sanofi to win approval in the past decade — a meaningful milestone in the French pharma's attempt to reenter the field after years of focusing more on diabetes and heart drugs.
- Approval of Sarclisa comes eight weeks ahead of schedule, making the antibody another example of the FDA's recent urgency to wave through new medicines. Since last fall, the agency has approved eight drugs at least two months before their scheduled decision date, four of which treat cancer.
Sarclisa is the seventh drug approved to treat multiple myeloma since Amgen's Kyprolis was cleared by the FDA in 2012. The influx of new treatments, which also includes Johnson & Johnson's blockbuster therapy Darzalex, has helped to extend survival times and given doctors options for when drugs stop working.
"Despite all the new therapies out there, the vast majority of patients are not cured. They are cycling through these therapies," said Dietmar Berger, global head of development at Sanofi, in an interview ahead of Sarclisa's approval.
Only patients who have tried and progressed on Celgene's Revlimid and another type of myeloma drug are eligible to receive Sarclisa, which is given in combination with a two-drug regimen of Bristol-Myers Squibb's Pomalyst and dexamethasone, known as pom-dex.
In a Phase 3 study, adding Sarclisa to pom-dex kept patients' cancer from progressing for a median of 11 and a half months, significantly better than the six and half with pom-dex alone. Just over 60% of treated patients responded to treatment, versus 35% on pom-dex.
Most patients experienced low white blood cell counts, and some had pneumonia or infections while on Sarclisa. Seven percent stopped taking the drug due to adverse events in the trial.
Sanofi priced Sarclisa at $650 per 100 mg vial, which, for the typical patient in the U.S., translates to a cost of $5,200 per infusion. The drug is administered every week for four weeks, and then every two weeks subsequently.
While Sarclisa is the eighth myeloma drug approved since 2012, it's only the second after Darzalex that's designed to target the CD38 protein on cancerous cells. Darzalex has become an important treatment option — winning half a dozen label expansions since its initial OK in November 2015 — and will likely be a formidable competitor to Sarclisa.
More treatments in development could further change myeloma treatment, too. Several pharmaceutical companies, including Bristol-Myers Squibb and J&J, are advancing cell therapies that target a subset of myelomas marked by a different protein.
Regeneron Pharmaceuticals, Amgen and GlaxoSmithKline, meanwhile, are developing twists on the standard antibody-based drug, hoping to improve their targeting or cancer-killing effects.
Competition aside, Sarclisa's approval gives a boost to Sanofi's cancer research efforts. Under new CEO Paul Hudson, the drugmaker has made oncology a greater emphasis, acquiring the immunotherapy-focused biotech Synthorx late last year for $2.5 billion.
Beyond Sarclisa, Sanofi has drugs aimed at lung and breast cancer, respectively, in Phase 3 and Phase 2 testing, and lists another six compounds in early-stage tests.
Last year, the drugmaker earned 1.7 billion euros in sales from its cancer drugs, well behind what it makes in diabetes, rare disease, immunology and multiple sclerosis. Its top-seller last year was Jevtana, approved in June 2010 for a type of prostate cancer.