HQ Team
February 21, 2024: Johnson & Johnson announced that USFDA had approved a bi-weekly dose of its blood cancer therapy Tecvayli.
The regulatory body approved, reduced doses of 1.5 milligrams per kilogram every two weeks in patients with relapsed or refractory multiple myeloma.
The patients should have achieved and maintained a complete response or better for a minimum of six months, according to a company statement.
Tecvayli was approved in October 2022 as an off-the-shelf (or ready-to-use) antibody for the treatment of adult patients with relapsed or refractory multiple myeloma.
The patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
Cancer starts in bone marrow
“This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials,” according to the statement.
The medicine has been prescribed to more than 3,600 patients in the US since approval, the company stated.
Multiple myeloma is a cancer of the plasma cells. Plasma cells are white blood cells that make antibodies that protect us from infection.
In myeloma, the cells grow too much, crowding out normal cells in the bone marrow that make red blood cells, platelets, and other white blood cells. Multiple myeloma — the most common type of plasma cell tumour — develops in the bone marrow and can spread throughout the body.
“Today’s approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules,” said Rachel Kobos, MD, VP, Oncology Research & Development, Johnson & Johnson Innovative Medicine.
Johnson & Johnson is an American pharmaceutical, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange.
