VERZENIO

批准信原文要点

This Prior Approval Supplemental New Drug Application provides for the addition of the following indication based on results from EMBER-3: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer: VERZENIO is a kinase inhibitor indicated in combination with imlunestrant for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA authorized test, with disease progression following at least one line of endocrine therapy.

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to Section 14 (Clinical Studies) of the USPI with the final overall survival results from monarchE.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to Section 8.4 (Pediatric Use) of the US Prescribing Information, to include data from Study I3Y-MC-JPCS (Study 1 from the Written Request letter) entitled “A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C)”. We note that Studies 2 and 3 from the Written Request letter are still ongoing.

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to Section 14 of the ‘Full Prescribing Information’ by adding updated overall survival (OS) data from the MONARCH 3 trial, which fulfills the requirement of PMC 3297-1, as noted in the original NDA 208855, approved February 26, 2018.

批准信原文要点

Prior Approval supplemental new drug application S-011 provides for an expanded indication for the use of Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node positive, early breast cancer at high risk of recurrence.

批准信原文要点

Prior Approval supplemental new drug application S-010 provides for an expanded indication for the use of Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

批准信原文要点

the addition of male patients to the indication for the use of abemaciclib in combination with fulvestrant for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy (Supplement 008).

批准信原文要点

the addition of male patients to the indication for the use of abemaciclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative advanced or metastatic breast cancer (Supplement 007).

批准信原文要点

new indication for the use of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score >20% as determined by an FDA approved test (Supplement 006).

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to section 14 of the Full Prescribing Information to add updated overall survival (OS) data from the MONARCH 2 trial.

批准信原文要点

This supplemental new drug application 003 (S-003) provides for revisions to the labeling for Verzenio (abemacicilib) consistent with our July 16, 2019, Safety Labeling Change Notification letter.

批准信原文要点

This Prior Approval supplemental new drug application proposes changes to Section 12.3 Pharmacokinetics, Drug Interaction Studies.