The U.S. Food and Drug Administration granted Johnson & Johnson's experimental blood cancer treatment JNJ-4528 its breakthrough therapy designation.
The regulator's designation is granted to accelerate the development and regulatory review of an investigational drug meant to treat a serious life-threatening disease.
J&J's Janssen Biotech Inc. unit is developing JNJ-4528 to treat patients of relapsed or refractory multiple myeloma who have previously undergone treatment. Multiple myeloma is a cancer that affects the plasma cells in the blood, which are responsible for producing antibodies.
Data from an ongoing phase 1b/2 study, dubbed Cartitude-1, supported the FDA designation. While J&J will present full results on Dec. 9 at the American Society of Hematology's annual meeting, data from the study, which is evaluating JNJ-4528 for treating the disease in adult patients, showed that the therapy reduced cancer in 90% of the patients.
The chimeric antigen receptor T cell, or CAR-T cell, therapy JNJ-4528 was previously granted the orphan drug designation by the FDA and priorities medicines, or PRIME, designation by the European Medicines Agency.
Amgen Inc. will also present results from a late-stage study of its multiple myeloma therapy Kyropolis at the ASH meeting. Also, Bristol-Myers Squibb Co. and bluebird bio Inc. released positive results from the KarMMa study which evaluated their CAR-T cell therapy ide-cel for the same indication.