COPIKTRA

批准信原文要点

Your proposed modification to the REMS consists of updating the REMS document, Section III. REMS Requirements under the section “Communication Materials & Dissemination Plans” to correct the timing for dissemination of REMS letters.

批准信原文要点

This Prior Approval sNDA provides for proposed modifications to the approved Copiktra (duvelisib) risk evaluation and mitigation strategy (REMS).

批准信原文要点

This Prior Approval sNDA provides for the following updates… based on the results from the DUO study… Addition of the new warning, “Treatment-Related Mortality” to the Boxed Warning and the Warnings and Precautions, Section 5. The Limitations of Use statement, “Copiktra is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality” was added…

批准信原文要点

Your proposed modifications to the REMS consists of removal of references to the follicular lymphoma indication from the Healthcare Provider REMS letter, Professional Society REMS letter, Fact Sheet, and the Copiktra REMS Program website.

批准信原文要点

This Prior Approval sNDA provides for revisions to the product labeling for the voluntary withdrawal of the follicular lymphoma indication from the US Prescribing Information and Medication Guide.

批准信原文要点

This Prior Approval sNDA provides for updates to the US Prescribing Information to include the additions of CYP3A inducer information to Sections 2.1 Dosing, 7.1 Drug Interactions, and 12.3 Clinical Pharmacology.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for bolding the font inside the Boxed Warnings in the Highlights and Full Prescribing sections of the US Prescribing Information.