FDA Approves Janssen Biotech’s Darzalex for Multiple Myeloma

The multiple myeloma treatment market has grown a little more crowded with the FDA’s approval of Janssen Biotech’s Darzalex.

The drug — which the agency approved for use in patients with blood cancer who have undergone at least three prior treatments — is the first monoclonal antibody approved for treating multiple myeloma.

Darzalex (daratumumab) was granted a wealth of special designations by the agency — to speed it to market and incentivize its continued development — including breakthrough designation, priority review, orphan drug status and accelerated approval.

Janssen spokeswoman Kellie McLaughlin says the company intends to put Darzalex on pharmacy shelves before the end of November. The company is pricing the injectable drug — which has a target market of roughly 12,500 patients — at $5,850 per treatment.

McLaughlin says that based on the drug’s rate of administration — once a week for the first two months, every two weeks for the next three months and monthly after that — the price is comparable to what other multiple myeloma drugs cost. She adds that this was based on an average dosing schedule of 7.4 months.

The FDA’s approval was based on two open-label studies Janssen conducted. While the agency normally frowns on open-label research, McLaughlin explains that the Phase 2 studies were never designed for approval, but they yielded such substantive results that the FDA was willing to forgo more rigorous clinical research to get the product to market sooner.

According to the FDA’s release, 29 percent of patients in the first study experienced complete or partial tumor reduction, while the second study garnered even better results: 36 percent of participants had complete or partial tumor reduction.