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Johnson & Johnson assures no impact on current treatments for multiple myeloma.
The CRL was issued based on factory inspections and is not related to safety or submitted data.
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The U.S. FDA filed a Complete Response Letter (CRL) for the supplemental Biologics License Application for Darzalex Faspro, (daratumumab & hyaluronidase-fihj) which is involved in a quadruplet regimen for newly diagnosed transplant-ineligible multiple myeloma. According to reports, the CRL was filed based on observations during facility inspections and is not associated with the safety and efficacy data submitted with the application.
“We are working closely with the FDA and are confident in our ability to promptly resolve the matter,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D. global therapeutic area head, oncology, innovative medicine, Johnson & Johnson. “Healthcare professionals and patients can be assured of no impact to the current use or supply of Darzalex and Darzalex Faspro, which are foundational therapies for treating multiple myeloma.”1
Despite FDA submitting the CRL, the agency did not request that Darzalex Faspro undergo new clinical studies, which is likely a positive indicator for the therapy. Additionally, FDA has reported that filing the CRL will not globally impact the product supply and/or the commercial availability of Darzalex Faspro.
The drug will also maintain its prior approval despite the motion and will remain available for all nine of the multiple myeloma U.S. indications. Following FDA filing the CRL, regulatory submissions, along with approvals in various global markets remain ongoing.
Before FDA filed its CRL for Darzalex Faspro, Johnson and Johnson’s treatment for multiple myeloma received FDA approval in May 2020 for nine indications, with four being frontline treatments for newly diagnosed patients, and held no restrictions on transplant eligibility. The treatment stands as the only FDA approved multiple myeloma treatment subcutaneously administering CD38-directed antibodies.
The Cepheus study is an ongoing, multicenter, randomized, open-label, Phase 3 study, comparing the efficiency and safety of Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone(D-Vrd), against VRd in the treatment of patients with newly diagnosed multiple myeloma and are transplant ineligible.
Results from the Cepheus study were introduced as a late breaking oral abstract back in 2024 at the International Myeloma Society Annual Meeting. The study results were also published in Nature Medicine, which divulged that participants of the study displayed noticeable improvement in overall minimal residual disease negativity rate, progression-free survival, and a complete response or better rate compared to standard multiple myeloma treatment options.
Additional information compiled during the Cepheus study, focused on the adverse effects of Darzalex Faspro monotherapy, which were the following.
Following the announcement of the FDA filing a CRL for Darzalex Faspro, Johnson & Johnson wrote in a press release “We are committed to resolving outstanding observations in a timely manner, with the goal of advancing this indication as soon as possible.”1
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