larotrectinib

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Generic Name:

larotrectinib

Project Status:

Complete

Therapeutic Area:

Solid tumours with NTRK gene fusion

Manufacturer:

Bayer Inc.

Brand Name:

Vitrakvi

Project Line:

Reimbursement Review

Project Number:

PC0221-000

Tumour Type:

Other

NOC Status at Filing:

Post NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For the treatment of adult and pediatric patients with solid tumours that: have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and, have no satisfactory treatment options.

Submission Type:

Resubmission

Fee Schedule:

Schedule A

Indications:

For the treatment of adult and pediatric patients with solid tumours that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity, and; have no satisfactory treatment options.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

September 13, 2021

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones²
Call for patient/clinician input open	October 16, 2020
Call for patient/clinician input closed	December 04, 2020
Clarification: - Patient input submission received from Lung Cancer Canada, The Canadian Breast Cancer Network, Colorectal Cancer Canada, Canadian Cancer Survivor Network and Sarcoma Cancer Foundation of Canada
Submission received	November 16, 2020
Submission accepted	November 30, 2020
Review initiated	December 01, 2020
Draft CADTH review report(s) provided to sponsor for comment	March 02, 2021
Deadline for sponsors comments	March 11, 2021
CADTH responses on draft review report(s) provided to sponsor	April 05, 2021
Expert committee meeting (initial)	April 15, 2021
Draft recommendation issued to sponsor	April 29, 2021
Draft recommendation posted for stakeholder feedback	May 07, 2021
End of feedback period	May 21, 2021
Clarification: - Reconsideration: major revisions requested by drug programs.
Expert committee meeting	August 11, 2021
Final recommendation issued to sponsor and drug plans	August 25, 2021
Final recommendation posted	September 13, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	September 09, 2021
CADTH review report(s) posted	November 12, 2021