A drug on the market for several years that has become a standard-of-care treatment for the blood cancer multiple myeloma now has a formulation available designed to make it easier to administer.
On Friday, the Food and Drug Administration approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of New Brunswick, New Jersey-based Johnson & Johnson’s drug Darzalex. The new formulation is approved for patients who are newly diagnosed and ineligible to be treated with stem cell transplant, as well as patients who have relapsed and refractory disease.
The original version of Darzalex, which is administered via intravenous infusion, has been on the market since 2015 and is administered over several hours, whereas the subcutaneous formulation is administered over three to five minutes.
“Since the approval of [Darzalex], a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings,” said Dr. Saad Usmani, division chief of plasma cell disorders at Atrium Health’s Levine Cancer Institute in Charlotte, North Carolina, in a statement on behalf of the drugmaker. “With Darzalex Faspro, there may be fewer administration-related reactions compared to intravenous Darzalex, providing an additional treatment option that may help patients, oncologists and nursing staff.”
The approval was based on results of the Phase III COLUMBA study, which were published in the journal Lancet Haematology this month. The study was designed to show whether Darzalex Faspro was non-inferior to intravenous Darzalex in terms of percentage of patients responding to therapy and maximum trough concentration, or Ctrough, which measures what the lowest concentration of a drug is before administration of the next dose. The published results of the trial showed that in terms of overall response rate and Ctrough, along with a better safety profile.
Darzalex is a monoclonal antibody that targets CD38, a cell-surface antigen widely expressed on myeloma cells. Another approved drug with the same antigen target is Sanofi’s Sarclisa (isatuximab-irfc), which received FDA approval in March. That drug is still administered intravenously, but an investigator in the clinical trial that led to its approval noted at the American Society of Clinical Oncology’s annual meeting last year that unlike Darzalex, it is not associated with complement activation, meaning it can be more readily administered to patients with underlying conditions like chronic obstructive pulmonary diseases. Because it binds to an epitope of CD38 distinct from that of Darzalex, it could also potentially be used in patients for whom Darzalex has failed.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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