The approval allows the therapy to be used in a reduced dosing of 1.5 milligrams per kilogram every two weeks, in patients who have achieved and maintained a complete response or better for a minimum of six months. Tecvayli was first approved in October 2022 for the treatment of adults with multiple myeloma that is hard to treat, or has come back after receiving at least four prior lines of certain classes of therapies. Multiple myeloma is a type of blood cancer that affects types of white blood cells called plasma cells, found in bone marrow.
Treatment with teclistamab led to responses in patients with relapsed/refractory multiple myeloma, including those previously exposed to anti-BCMA therapies.
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FDA approval of Tecvayli, from Johnson & Johnson subsidiary Janssen Biotech, makes it the newest therapy that treats multiple myeloma by targeting the cancer protein BCMA. Though this off-the-shelf drug offers patients a more convenient dosing option, it comes with similar complication risks as other biologics approved for this type of blood cancer.
First European Commission approval of a bispecific antibody discovered using OmniAb OmniAb, Inc. is eligible to receive a $10 million milestone upon first commercial sale in Europe Ligand Pharmaceuticals