Larotrectinib for Neurotrophic Tyrosine Receptor Kinase (NTRK) Locally Advanced or Metastatic Solid Tumours – Details


( Last Updated : November 15, 2019)
Generic Name:
Larotrectinib
Project Status:
Complete
Therapeutic Area:
NTRKplus solid tumours
Manufacturer:
Bayer Inc.
Brand Name:
Vitrakvi
Project Line:
Reimbursement Review
Project Number:
PC0159-000
NOC Date:

Details


Strength:
25 mg, 100 mg & 20 mg/mL
Tumour Type:
Other
Indications:
Neurotrophic Tyrosine Receptor Kinase (NTRK) Locally Advanced or Metastatic Solid Tumours
Funding Request:
For the treatment of adult and pediatric patients with locally advanced or metastatic solid tumours harbouring a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. Additional criteria: Age ≥ 1 month; ECOG score of ≤3; Tumour harbouring NTRK1, NTRK2 or NTRK3 gene fusion confirmed by a validated diagnostic testing method; Patients eligible for larotrectinib should have no satisfactory alternative treatments or have progressed following treatment
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Bayer Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Do not reimburse
Funding Request:
For the treatment of adult and pediatric patients with locally advanced or metastatic solid tumours harbouring a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. Additional criteria: Age ≥ 1 month; ECOG score of ≤3; Tumour harbouring NTRK1, NTRK2 or NTRK3 gene fusion confirmed by a validated diagnostic testing method; Patients eligible for larotrectinib should have no satisfactory alternative treatments or have progressed following treatment
pERC Meeting:
Final Recommendation Issued:

Files

‡ 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.