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Olaratumab for Advanced Soft Tissue Sarcoma – Details

Project Number pCODR 10111
Brand Name TBD
Generic Name Olaratumab
Strength 10 mg/mL
Tumour Type Sarcoma
Indication Advanced Soft Tissue Sarcoma (STS)
Funding Request In combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and for whom treatment with an anthracycline-containing regimen is appropriate
Review Status Under Review
Pre Noc Submission Yes
NOC Date November 23, 2017
Manufacturer Eli Lilly Canada Inc.
Submitter Eli Lilly Canada Inc.
Submission Date October 26, 2017
Submission Deemed Complete November 2, 2017
Submission Type New Indication
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ November 9, 2017
Check-point meeting (target date) December 13, 2017
pERC Meeting (target date)
Clarification The Submitter notified pCODR that they will be unable to submit by their original target date and an updated target submission date has been provided.
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ 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.