Johnson & Johnson’s cancer drug, Darzalex Faspro, has been approved by the FDA for use in a very early stage of multiple myeloma, a type of blood cancer. This is the first time a drug has been approved for this specific use. Darzalex Faspro is a type of medicine called a monoclonal antibody, which targets a specific part of the cancer cells. The FDA approved this drug based on a large study called AQUILA, which showed that Darzalex Faspro significantly delayed the progression of the disease compared to the current standard approach of ‘watchful waiting’. In this study, the drug reduced the risk of the disease getting worse or causing death by 51%. The most common side effects of Darzalex Faspro in this study were diarrhea, tiredness, muscle and bone pain, skin rash, sleep problems, upper respiratory infections, nerve damage, and reactions at the injection site. Experts believe that this approval could change the way multiple myeloma is treated, as it is usually only treated when it becomes more active. This approval means that Darzalex Faspro is now approved for use in ten different situations involving multiple myeloma, including four in newly diagnosed patients. It is also the first drug approved for use in a specific type of amyloidosis, a disease that can affect the heart and other organs. Darzalex Faspro has been a big seller for Johnson & Johnson, bringing in $3.6 billion in the third quarter of 2025 alone. Experts predict that it will continue to be a major driver of growth in the multiple myeloma market up to 2032. However, they also note that the long-term nature of the treatment, the risk of infections, and the need for careful patient selection and monitoring will be important factors in its use. The approval of Darzalex Faspro for this early stage of multiple myeloma is expected to increase its use and reinforce Johnson & Johnson’s leading position in the treatment of this disease. However, the strict criteria for who can receive the drug and insurance company policies may limit its use in this early stage.