HQ Team
August 1, 2024: The US Food and Drug Administration has approved the Darzalex Faspro combination drug therapy of Janssen Research and Development for treating blood cancer.
The approval for the drug for multiple myeloma, in combination with bortezomib, lenalidomide, and dexamethasone, comes after end trials showed a reduction in the risk of disease progression or death by 60% compared to the standard therapy.
Multiple myeloma is a blood cancer that develops in plasma cells in the bone marrow— the soft, spongy tissue at the centre of bones.
In healthy bone marrow, normal plasma cells make antibodies to protect your body from infection.
Independent review
Efficacy was evaluated during trials in patients 70 years of age and younger. A total of 709 patients were randomised, 355 to the Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone group and 354 to the bortezomib, lenalidomide, and dexamethasone (VRd) group.
The major efficacy outcome measure was progression-free survival, as assessed by an independent review committee based on the International Myeloma Working Group response criteria, according to a July 30 statement from the FDA.
The most common adverse reactions of 20% or more were peripheral neuropathy, fatigue, oedema, pyrexia, upper respiratory infection, constipation, diarrhoea, musculoskeletal pain, insomnia, and rash.
“This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
“This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics,” according to the USFDA statement.
Genetic mutations
In multiple myeloma, plasma cells are transformed into cancerous cells that grow out of control, crowding out the normal cells that help fight infection.
These malignant plasma cells then produce an abnormal antibody called M-protein, high levels of which are a hallmark characteristic of multiple myeloma.
Multiple myeloma is caused by certain genetic mutations, and these mutations are different from person to person. But though certain mutations have been identified as risk factors for myeloma, multiple myeloma is not thought to be a hereditary disease.
The mutations that cause multiple myeloma are not passed down through families the way certain physical traits or diseases like cystic fibrosis or sickle cell disease are. Rather, the mutations that cause myeloma likely develop spontaneously as people age.
The rate of new cases of myeloma was 7.2 per 100,000 men and women per year, according to the National Cancer Institute.
The death rate was 3.0 per 100,000 men and women per year. These rates are age-adjusted and based on 2017–2021 cases and 2018–2022 deaths.
