Johnson & Johnson’s Darzalex Faspro has received approval from the U.S. Food and Drug Administration (FDA) for use as part of a four-drug regimen in treating newly diagnosed multiple myeloma patients who are not eligible for stem cell transplantation.
According to Johnson & Johnson, this marks the twelfth overall indication and fifth frontline indication for Darzalex Faspro. The new approved regimen combines Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone—a combination commonly referred to as VRd.
The FDA based its decision on results from the Phase III CEPHEUS study. At a median follow-up of 22 months, 52.3% of patients treated with the Darzalex Faspro regimen achieved minimal residual disease (MRD) negativity, compared to 34.8% among those who received only VRd. MRD negativity is defined as the absence of cancer cells per 100,000 bone marrow cells.
The data also showed that adding Darzalex Faspro to VRd reduced the risk of disease progression or death by 40% at 39 months when compared to VRd alone. However, overall survival data from CEPHEUS were not mature at the time of this label expansion.
Darzalex Faspro is a subcutaneous version of intravenous Darzalex, which was first approved by the FDA in 2015 for patients with multiple myeloma who had previously undergone at least three lines of therapy. The subcutaneous formulation received its initial FDA approval in 2020 for relapsed or refractory multiple myeloma.
Since then, Darzalex Faspro has expanded its role in treating multiple myeloma through additional indications. In November last year, it was approved by the FDA for high-risk smoldering multiple myeloma, an asymptomatic and pre-malignant stage of the disease.
In December, the FDA granted Darzalex Faspro a Commissioner’s National Priority Voucher for its investigational combination with J&J’s bispecific antibody Tecvayli in relapsed or refractory multiple myeloma cases. This voucher could expedite review times for future applications involving this treatment combination to one or two months.
Other recently approved treatments for multiple myeloma include Regeneron’s bispecific antibody Lynozyfic and GSK’s antibody-drug conjugate Blenrep. Blenrep had initially received accelerated approval in August 2020 but was withdrawn from the market in November 2022 after failing a confirmatory study; it returned to the market last October.
