Europe Approves Reduced Dosing For Johnson & Johnson's Cell Therapy For Multiple Myeloma
Portfolio Pulse from Vandana Singh
The European Commission has approved a Type II variation application for Tecvayli (teclistamab), a cell therapy for multiple myeloma developed by Johnson & Johnson's Janssen Pharmaceutical Companies. The approval allows for a reduced dosing frequency in patients who have achieved a complete response for a minimum of six months. The approval was supported by positive results from the Phase 1/2 MajesTEC-1 study. In October 2022, the FDA approved Tecvayli for relapsed or refractory multiple myeloma for patients who previously received four or more prior lines of therapy.

August 18, 2023 | 3:59 pm
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NEUTRAL IMPACT
The European approval for reduced dosing of Johnson & Johnson's cell therapy for multiple myeloma could potentially increase the drug's usage and sales in Europe. However, JNJ shares are currently down 0.98%.
The approval for reduced dosing of Tecvayli could potentially increase its usage among patients who have achieved a complete response for a minimum of six months, thereby increasing its sales in Europe. However, the impact on JNJ's stock price is uncertain as the shares are currently down 0.98%.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 100