Abiraterone (Zytiga) for Prostate Cancer Resubmission - Details

Details

Generic Name:
Abiraterone
Project Status:
Withdrawn
Therapeutic Area:
Prostate Cancer Resubmission
Manufacturer:
Janssen Inc.
Brand Name:
Zytiga (Resubmission)
Project Line:
Reimbursement Review
Project Number:
PC0201-000
Strength:
250 mg & 500 mg
Tumour Type:
Genitourinary
Indications:
Prostate Cancer
Funding Request:
Newly diagnosed high-risk metastatic castration sensitive prostate cancer without small-cell histologic features. Patients required to have at least two of the three following high-risk factors: Gleason score of 8 or more, at least 3 bone lesions, and presence of visceral metastasis. Less than 3 months of androgen deprivation therapy (or orchiectomy) for metastatic disease. Eligible for abiraterone therapy.
Review Status:
Withdrawn
Sponsor:
BC Cancer Agency
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Clarification:
Voluntarily withdrawn by the sponsor on April 6, 2021

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.