Johnson & Johnson Reports the US FDA’s Approval of Tecvayli for Treating Relapsed/Refractory Multiple Myeloma (RRMM)
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- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
