Darzalex Faspro, in combination with an anti-cancer triplet, is the first anti-CD38-based regimen for newly diagnosed patients with multiple myeloma, regardless of eligibility for stem cell transplantation.
The FDA has greenlit the use of Johnson & Johnson’s Darzalex Faspro as part of a four-drug regimen for the treatment of newly diagnosed patients with multiple myeloma who cannot undergo stem cell transplantation.
The approval marks Darzalex Faspro’s twelfth indication overall and fifth in the frontline setting, according to the pharma’s news release on Tuesday. This new treatment regimen combines Darzalex Faspro with the proteasome inhibitor bortezomib, the immunomodulator lenalidomide and the corticosteroid dexamethasone—a triplet known via the shorthand VRd.
Data from the Phase III CEPHEUS study supported the FDA’s approval. At a median follow-up of 22 months, the study found that 52.3% of patients treated with the Darzalex Faspro regimen achieved minimal residual disease (MRD) negativity, a metric defined as the absence of cancer cells per 100,000 bone marrow cells. In patients treated with just VRd alone, 34.8% reached MRD negativity, according to Tuesday’s release.
Darzalex Faspro plus VRd also cut the risk of disease progression or death by 40% versus VRd controls at 39 months. Overall survival data from CEPHEUS had not yet matured at the time of the label expansion.
Darzalex Faspro is a subcutaneous reformulation of the intravenous Darzalex, which the FDA first approved in 2015 for patients with multiple myeloma who had undergone at least three prior lines of therapy. The under-the-skin injection came later, with an FDA approval in 2020 for relapsed or refractory multiple myeloma.
The franchise has since grown its presence in the multiple myeloma space with more indications. In November last year, for instance, Darzalex Faspro won the FDA’s nod for high-risk smoldering multiple myeloma, an asymptomatic and pre-malignant form of the disease.
A month later, the FDA also proactively awarded Darzalex Faspro its Commissioner’s National Priority Voucher for its investigational combination regimen with J&J’s bispecific antibody Tecvayli—also for the treatment of relapsed or refractory multiple myeloma. The ticket could help further expand the franchise’s presence in this disease space by shortening its review period down to 1–2 months.
Other multiple myeloma drugs recently approved include Regeneron’s bispecific antibody Lynozyfic and GSK’s antibody-drug conjugate Blenrep, which last October made a comeback in this space. Blenrep was originally given accelerated approval in August 2020 for relapsed or refractory multiple myeloma, but GSK withdrew it from the market in November 2022 after a failed confirmatory study.
