Summary of Cancellation for Trastuzumab (*Tuznue)
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Contact:
Medicinal ingredient(s):
Trastuzumab
Therapeutic area:
Antineoplastic Agents
Type of submission:
New Drug Submission
Control number:
253850
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
2023-06-30
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek authorization of Tuznue (trastuzumab 440 mg/vial and 150 mg/vial lyophilized powder for solution for intravenous infusion), as a biosimilar to Herceptin (trastuzumab 440 mg/vial lyophilized powder for solution for intravenous infusion), for the indications and clinical uses currently held by Herceptin in Canada: for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer.
What did the company submit to supports its submission?
The sponsor submitted quality (biosimilarity, and chemistry and manufacturing data), nonclinical, and clinical data packages to support the submission. Following the initial review of the NDS, a Notice of Deficiency (NOD) from a quality perspective was issued by Health Canada on May 31, 2022. A response to the NOD was accepted for review on November 27, 2022.
The pivotal clinical safety, efficacy, and clinical pharmacology information consisted of the following:
Troika: A phase III, randomised, double-blind, parallel-group, multicentre, clinical study in women with HER2-positive early breast cancer to evaluate the efficacy, safety and immunogenicity of Tuznue compared to EU-Herceptin.
Troika 1: A phase I, double-blind, randomized, parallel group study to demonstrate the biosimilarity in pharmacokinetic properties of a single intravenous dose of Tuznue versus EU-Herceptin and US-Herceptin in healthy male subjects.
A supportive clinical pharmacology study was also submitted:
EAGLE-I-12: A Phase I, double-blind, randomized, parallel group study to demonstrate the biosimilarity in pharmacokinetic properties of a single intravenous dose of Tuznue versus EU-Herceptin in healthy male subjects.
Lastly, the sponsor also submitted a non-clinical repeat-dose study performed in cynomolgus monkey over a period of 4 weeks followed by a 4-week recovery period to evaluate the toxicity of the intravenous treatment.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, Health Canada had not completed the review of the quality data provided to support the submission. The quality data submitted in response to the NOD were inadequate to address the concerns identified in the NOD. The sponsor chose to cancel the submission without prejudice to refiling. At the time of cancellation, the non-clinical and clinical review by Health Canada was not initiated.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
Tuznue is a proposed biosimilar to Herceptin (trastuzumab) and other trastuzumab products are authorized by Health Canada; therefore, there is no expected impact to patients. The cancellation has no impact to access through the Special Access Programme or clinical trials.
*Proposed Brand Name:
Tuznue
Manufacturer:
Prestige Biopharma Ltd.
Drug Identification Numbers issued:
N/A
Date filed:
2021-07-05