Regulatory Decision Summary for Bevluma

 

Decision issued

No decision was issued by Health Canada. The company chose to cancel its submission before a final decision was issued.

Date of cancellation

September 23, 2021

What was the purpose of this submission?

The sponsor was seeking authorization of the biosimilar FKB238 (Bevluma) for the following indications in the reference medicinal product Avastin (bevacizumab), in intravenous (IV) use for:

• First-line therapy for metastatic colorectal cancer (mCRC) in combination with fluoropyrimidine-based chemotherapy;
• Combination therapy with carboplatin/paclitaxel chemotherapy for locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC);
• Combination therapy with paclitaxel, topotecan or pegylated liposomal doxorubicin for platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer;
• Combination therapy with lomustine for malignant glioma (WHO grade IV) - glioblastoma.

What did the company submit to support its submission?

The sponsor provided one pharmacokinetic study (FKB238-001) with male participants, and one non-squamous (NS) NSCLC related study (FKB238-002, the pivotal trial for this New Drug Submission). NS-NSCLC was considered the most sensitive population to assess clinical efficacy of bevacizumab. Study FKB238-002 was designed to compare the efficacy and safety of FKB238 (Bevluma) to Avastin.

The primary objective was to demonstrate the efficacy equivalence between these drugs when used in combination with paclitaxel and carboplatin as measured by Overall Response Rate (ORR). Patients presented with advanced or recurrent NS-NSCLC, receiving first-line treatment.

The primary efficacy endpoint was the ORR as assessed by a blinded independent central review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). The ORR was defined as the proportion of patients with complete response or partial response as the best overall response. The study met its primary objective since the 95% confidence interval of the ratio of ORR was within the pre-defined equivalence margin of (0.73, 1.38).

The secondary endpoints supported the primary analyses and confirmed efficacy equivalence and there were no clinically meaningful differences between FKB238 and Avastin.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

At the time of the cancellation, the review of the clinical, non-clinical and chemistry data packages was complete. The company canceled the submission due to business reasons.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials.

Additional information

*Proposed Brand Name:
Bevluma