TECVAYLI

批准信原文要点

Your proposed modification to the REMS consists of an update to the REMS Dispense Authorization (RDA) requirement to reduce administrative burden on pharmacies and healthcare settings.

批准信原文要点

This Prior Approval sBLA provides for the following updates: • Conversion from accelerated approval to traditional approval for teclistamab as monotherapy, in adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. • New indication of teclistamab in combination with daratumumab hyaluronidase-fihj for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. • Modifications to the approved Tecvayli and Talvey risk evaluation and mitigation strategy (REMS)

批准信原文要点

Your proposed modifications to the REMS consist of updates to the Tecvayli and Talvey Adverse Reaction Management Guide to reflect the revisions to the Talvey (talquetamab-tgvs) USPI in the Dosage and Administration, Dosage Modifications for Adverse Reactions (Section 2.5) to add a footnote for managing Neurologic Toxicity to include ataxia/balance disorder, and to update the Tecvayli and Talvey Patient Wallet Card to reflect the revisions in the USPI from the Patient Counseling Information, Neurologic Toxicity including ICANS (Section 17) to add symptoms of ataxia/cerebellar ataxia.

批准信原文要点

This Prior Approval sBLA provides for revisions to the US Prescribing Information (USPI) in the Boxed Warning and the Warnings and Precautions section under Section 5.2 to include “fatal” neurologic toxicities including immune effector cell-associated neurotoxicity syndrome (ICANS) and proposed modifications to the approved Tecvayli and Talvey risk evaluation and mitigation strategy (REMS).

批准信原文要点

Your proposed modifications to the REMS consist of updating the Talvey logo, moving the trademark symbols for Talvey and Tecvayli to REMS materials headers, a change in the manufacturer’s logo, phone and email updates, and date versioning.

批准信原文要点

Your proposed modifications to the REMS consists of addition of the ‘delegate function’ to the Pharmacy and Healthcare Setting Training Program, deletion of the ‘Pharmacy and Healthcare Setting Reattestation Requirements’ from the Pharmacy and Healthcare Setting Training, deletion of the ‘Important Program Updates’ pop-up from the Tecvayli and Talvey REMS Website, and addition of the Prescriber Enrollment Form to the Tecvayli and Talvey REMS Website.

批准信原文要点

Your proposed modifications to the REMS consists of addition of the ‘delegate function’ to the Pharmacy and Healthcare Setting Training Program, deletion of the ‘Pharmacy and Healthcare Setting Reattestation Requirements’ from the Pharmacy and Healthcare Setting Training, deletion of the ‘Important Program Updates’ pop-up from the Tecvayli and Talvey REMS Website, and addition of the Prescriber Enrollment Form to the Tecvayli and Talvey REMS Website.

批准信原文要点

This Prior Approval supplemental biologics application provides for revisions to the United States Prescribing Information (USPI) to reflect the addition of progressive multifocal leukoencephalopathy as a clinically relevant adverse reaction under Section 6 Adverse Reactions of the USPI.

批准信原文要点

This Prior Approval sBLA provides for updates to the Tecvayli (teclistamab-cqyv) US Prescribing Information and Medication Guide with a revised dosing regimen in patients who have achieved and maintained a complete response or better for a minimum of 6 months, the dosing frequency may be decreased to 1.5 mg/kg every two weeks until disease progression or unacceptable toxicity. In addition, this Prior Approval sBLA provides for modifications to the approved Tecvayli and Talvey risk evaluation and mitigation strategy (REMS) to incorporate the revised dosing regimen for Tecvayli (teclistamab).

批准信原文要点

This corrected action letter incorporates the correction of the error. The effective action date will remain November 16, 2023, the date of the original letter. This Changes Being Effected sBLA provides for the addition of Spanish and Mandarin Patient Wallet Cards to the Tecvayli and Talvey REMS website.

批准信原文要点

This Prior Approval sBLA provides for updating the risk evaluation and mitigation strategy (REMS) name from TECVAYLI REMS to TECVAYLI and TALVEY REMS in the labeling and proposed modifications to the approved TECVAYLI REMS to form a combined REMS with talquetamab.