FDA Approves Johnson & Johnson's Reduced Tecvayli Dosing In Pretreated Multiple Myeloma Patients
Portfolio Pulse from Vandana Singh
The FDA has approved Johnson & Johnson's (NYSE:JNJ) application for a reduced dosing frequency of Tecvayli in patients with relapsed or refractory multiple myeloma (RRMM) who have maintained a complete response for at least six months. This approval, based on the Phase 1/2 MajesTEC-1 study, allows for a dosing frequency of 1.5 mg/kg every two weeks. Tecvayli, a bispecific antibody targeting BCMA and CD3, was initially approved in October 2022 for RRMM patients after at least four prior lines of therapy. Over 3,600 patients in the U.S. have been prescribed Tecvayli since its approval.
February 21, 2024 | 4:04 pm
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Johnson & Johnson receives FDA approval for reduced dosing frequency of Tecvayli in certain multiple myeloma patients, based on positive Phase 1/2 study results. Over 3,600 patients have been prescribed Tecvayli since its initial approval.
The FDA approval for a reduced dosing frequency of Tecvayli in RRMM patients who have maintained a complete response for at least six months is a significant development for Johnson & Johnson. This approval could potentially increase the drug's usage and patient adherence due to the less frequent dosing requirement, positively impacting JNJ's stock in the short term. The fact that over 3,600 patients have already been prescribed Tecvayli since its initial approval indicates a strong market presence and potential for growth following this new approval.
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