CDA | Evidence Driven
CDA | Evidence Driven

Xalkori Resubmission for First Line Advanced NSCLC - Details

Details

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Generic Name:
Crizotinib
Project Status:
Complete
Therapeutic Area:
First Line ALK Positive Advanced NSCLC
Manufacturer:
Pfizer Canada Inc.
Brand Name:
Xalkori
Project Line:
Reimbursement Review
Project Number:
PC0054-000
Performance Metric:
N/A — Predated performance metrics
Strength:
200mg and 250mg capsules
Tumour Type:
Lung
Indications:
First Line ALK Positive Advanced NSCLC
Funding Request:
As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). The study PROFILE1014 will provide data specific to the efficacy and safety of Xalkori for the first-line treatment of ALK-positive advanced NSCLC patient population.
Review Status:
Complete
Sponsor:
Pfizer Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
Check-point meeting (target date):
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Crizotinib Resubmission First Line NSCLC - Final Recommendation Final Recommendation July 21, 2015 View PDF
Crizotinib Resubmission First Line NSCLC - Final Clinical Guidance Report Guidance Reports July 21, 2015 View PDF
Crizotinib Resubmission First Line NSCLC - Final Economic Guidance Report Guidance Reports July 21, 2015 View PDF
Crizotinib Resubmission First Line NSCLC - Initial pERC Recommendation Initial Recommendation July 3, 2015 View PDF
Crizotinib Resubmission First Line NSCLC - PAG Feedback on Initial Recommendation Feedback July 21, 2015 View PDF
Crizotinib Resubmission First Line NSCLC - Manufacturer Feedback on Initial Recommendation Feedback July 21, 2015 View PDF
Crizotinib Resubmission First Line NSCLC - Patient Advocacy Group (OLA) COI Declarations COI Declarations July 21, 2015 View PDF
Crizotinib Resubmission First Line NSCLC - Patient Advocacy Group (LCC) COI Declarations COI Declarations July 21, 2015 View PDF

‡ 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.

Last Updated : August 6, 2015