Mississauga, July 22, 2021 – Bayer Inc. (Bayer) received the draft, positive tumour-agnostic reimbursement recommendation for VITRAKVI® (larotrectinib) issued by the Canadian Agency for Drugs and Technologies in Health (CADTH), pan-Canadian Oncology Drug Review (pCODR) and Expert Review Committee (pERC) in May 2021. The draft recommendation is great news for pediatric and adult TRK fusion cancer patients with metastatic or locally advanced solid tumors that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion and currently have no satisfactory treatment options. 

VITRAKVI® was approved by Health Canada in 2019, under the Notice of Compliance with conditions pathway, as the first tumour-agnostic cancer treatment in Canada. The draft CADTH recommendation is the first positive recommendation to support this indication for reimbursement. However, there is a current request for major revisions by the provinical drug programs highlighting concerns with the draft recommendation.

Bayer acknowledges the implementation challenges associated with tumour agnostic treatments and is committed to working with payers and healthcare providers. We look forward to meaningful and constructive dialogues with provincial stakeholders and the pan-Canadian Pharmaceutical Alliance to find ways to work in partnership to address implementation concerns. This includes discussing how Bayer’s existing patient support program (TRAKTION) and complimentary NTRK gene fusion testing program (FastTRK) could be supportive so Canadian patients have access to this innovative and effective treatment.

VITRAKVI (larotrectinib) is indicated 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,
• has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit.

Patients should be advised of the nature of the authorization. For further information for VITRAKVIR please refer to Health Canada’s Notice of Compliance with conditions – drug products web site (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/index-eng.php).

This indication is approved based on overall response rate (ORR) and duration of response (DOR) in a pooled patient population in which most patients had rare tumours. Treatment with VITRAKVI should be initiated following confirmation of an NTRK gene fusion in a tumour specimen using a validated test. VITRAKVI should only be administered under the supervision of a health professional experienced in the use of antineoplastic agents.

Please consult the Product Monograph at www.bayer.ca/omr/online/vitrakvi-pm-en.pdf
for important information relating to conditions of clinical use, contraindications, warnings, precautions, adverse reactions, drug interactions and dosing information. The Product Monograph is also available by calling Bayer Medical Information at 1-800-265-7382 or email canada.medinfo@bayer.com.