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Entrectinib (TBD) for Neurotrophic Tyrosine Receptor Kinase (NTRK) Fusion-Positive Solid Tumours

Project Number PC0157-000
Brand Name TBD
Generic Name Entrectinib
Tumour Type Other
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.
Review Status Withdrawn
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
NOC Date
Manufacturer Hoffmann-La Roche Limited
Sponsor Hoffmann-La Roche Limited
Submission Date July 29, 2019
Submission Deemed Complete August 23, 2019
Submission Type Initial
Prioritization Requested
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.