Xalkori for Advanced NSCLC - Resubmission - Details

Details

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Generic Name:
Crizotinib
Project Status:
Complete
Therapeutic Area:
Advanced or Metastatic Non-Small Cell Lung Cancer
Manufacturer:
Pfizer Canada Inc.
Brand Name:
Xalkori
Project Line:
Reimbursement Review
Project Number:
PC0017-000
Strength:
200mg and 250mg
Tumour Type:
Lung
Indications:
Advanced Non-Small Cell Lung Cancer
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)
Review Status:
Complete
Sponsor:
Pfizer Canada Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
As per pCODR Procedures D3.2, due to the short time frame between the original submission and the resubmission, pCODR will not be seeking new patient advocacy group input. The most recent patient advocacy group input received on the original submission related to Crizotinib (Xalkori) for Advanced NSCLC will be provided to the Review Team to incorporate into the Clinical and Economic Guidance Reports and to pERC for the purposes of their deliberation.
pERC Meeting:
Final Recommendation Issued:

The manufacturer, Pfizer Canada Inc. has resubmitted to pCODR for the Crizotinib (Xalkori) Advanced NSCLC submission. Please see the Crizotinib (Xalkori) for Advanced NSCLC Details page for information pertaining to the original submission.

‡ 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.