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|Project Number||pCODR 10157|
|Indication||Neurotrophic Tyrosine Receptor Kinase (NTRK) Fusion-Positive Solid Tumours|
|Funding Request||For the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients.|
|Clarification||Hoffmann-La Roche Limited has requested a voluntary withdrawal of the pCODR 10157 Entrectinib (TBD) for NTRK+ solid tumours submission.|
|Pre Noc Submission||Yes|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||July 29, 2019|
|Submission Deemed Complete||August 23, 2019|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||August 13, 2019|
|Check-point meeting||October 23, 2019|
|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|
‡ 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.