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Mvasi for Metastatic Colorectal Cancer / Non-Small Cell Lung Cancer Biosimilar – Details

Project Number PC0158-000
Brand Name Mvasi
Generic Name Bevacizumab
Strength 100 mg and 400 mg
Tumour Type Gastrointestinal / Lung
Indication Metastatic Colorectal Cancer / Non-Small Cell Lung Cancer Biosimilar
Funding Request For first-line treatment of patients with metastatic carcinoma of the colon or rectum, in combination with fluoropyrimidine based chemotherapy / For treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer, in combination with carboplatin/paclitaxel chemotherapy regimen
Review Status Complete
Pre Noc Submission No
NOC Date April 30, 2018
Manufacturer Amgen Canada Inc.
Sponsor Amgen Canada Inc.
Submission Date October 3, 2018
Submission Deemed Complete October 18, 2018
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ October 18, 2018
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued
Therapeutic Area mCRC NSCLC Biosimilar
Recommendation Type n/a

‡ 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.