Shots:

• The US FDA has approved Tecvayli for RRMM at a reduced dosing frequency of 1.5mg/kg, Q2W for patients who have maintained a CR or better for at least 6mos.
• The approval was supported by the P-I/II (MajesTEC-1) trial where the P-I dose escalation & expansion study assessed the safety, tolerability, PK and preliminary efficacy of Tecvayli while the P-II trial tested the efficacy of the drug at the RP2D (1.5mg/kg, SC, QW)
• The results, presented in Jun 2023, depicted sustained responses with Tecvayli in patients who experienced CR while those who switched from weekly to biweekly dosing, after the median follow-up of 12mos., maintained response to the drug resulting in lesser grade 3 or higher infections

Ref: Johnson & Johnson | Image: Johnson & Johnson

Related news:- Janssen’s Tecvayli (teclistamab) Receives Type II Variation Application Approval from EC for Relapsed and Refractory Multiple Myeloma

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