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The FDA declined approval of Darzalex Faspro for newly diagnosed, transplant-ineligible multiple myeloma in its current form.
A complete response letter (CRLs) was issued by the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application of Darzalex Faspro (daratumumab and hyaluronidase-fihj) which is used in a quadruplet regimen for newly diagnosed, transplant-ineligible multiple myeloma, according to a news release from Johnson & Johnson. The news release notified the company that the investigational agent could not be approved in it’s current form
Complete response letters are written notices the FDA sends to a drug company when it reviews an application for a new drug or biological product and decides it cannot approve it in its current form, according to the FDA’s website, fda.gov. These letter’s outline the specific issues the FDA found, such as safety concerns, questions about effectiveness, manufacturing problems or missing data. The letter may also suggest what changes or additional studies are needed before the company can resubmit its application.
Regarding key findings, there is no impact on the global supply or availability of Darzalex Faspro, which remains approved in the U.S. for all nine multiple myeloma indications. Regulatory reviews in other countries are ongoing, and the European Commission recently approved its use in newly diagnosed patients who are eligible for a stem cell transplant, based on results from the phase 3 CEPHEUS study.
“We are working closely with the FDA and are confident in our ability to promptly resolve the matter,” Dr. Yusri Elsayed, Global Therapeutic area head, Oncology, Innovative Medicine, Johnson & Johnson, said in the news release. “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.”
Progression-free survival: time during and after treatment in which the disease does not worsen.
Minimal residual disease: presence of small numbers of cancer cells that remain after treatment and are detectable with sensitive techniques.
Complete response: disappearance of all signs of cancer in response to treatment.
The CEPHEUS study results were presented at the 2024 International Myeloma Society Annual Meeting and later published in Nature Medicine. The Darzalex Faspro treatment group showed meaningful improvements in minimal residual disease (MRD) negativity, progression-free survival (PFS) and complete response (CR) rates compared with standard treatment.
CEPHEUS is an ongoing, multicenter phase 3 study testing the safety and effectiveness of Darzalex Faspro in combination with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone (D-VRd) compared with VRd in patients with newly diagnosed multiple myeloma who are not eligible for a stem cell transplant.
Darzalex Faspro was approved in the United States in May 2020 and is now approved for nine uses in multiple myeloma, including four for newly diagnosed patients who may or may not be eligible for a stem cell transplant. It is the only CD38-targeted antibody available as a subcutaneous (under-the-skin) injection for treating multiple myeloma. Darzalex Faspro is combined with hyaluronidase to help deliver the medicine.
In multiple myeloma, the most common side effect with Darzalex Faspro given alone is upper respiratory tract infection. When used in combination with other medicines, common side effects include fatigue, nausea, diarrhea, shortness of breath, trouble sleeping, headache, fever, cough, muscle spasms, back pain, vomiting, high blood pressure, upper respiratory tract infection, nerve problems such as tingling or numbness in the hands and feet (peripheral neuropathy), constipation, pneumonia, and swelling in the hands, ankles, or feet.
Darzalex was first approved in the United States in November 2015 and is approved for eight uses, including three for newly diagnosed patients who may or may not be eligible for a stem cell transplant.
It was also the first CD38-targeted antibody approved for multiple myeloma, and treatment combinations that include Darzalex have been given to nearly 650,000 patients worldwide.
With intravenous Darzalex, the most commonly reported side effects include upper respiratory tract infection, low white blood cell counts (neutropenia, leukopenia, lymphopenia), infusion-related reactions, low platelet counts (thrombocytopenia), diarrhea, constipation, anemia, nerve problems in the hands and feet, fatigue, swelling, nausea, cough, fever, shortness of breath, and weakness (asthenia).
Low blood counts are also common with Darzalex, including neutropenia, lymphopenia, thrombocytopenia, leukopenia and anemia.
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