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January 28, 2021 - The FDA has accepted a biologics license application for BAT1706, a proposed biosimilar to bevacizumab.
The FDA has accepted a biologics license application (BLA) for BAT1706, a proposed biosimilar to bevacizumab (Avastin), according to an announcement made by Bio-Thera Solutions.1
If approved, the biosimilar will be indicated for use in the treatment of patients with metastatic colorectal cancer plus fluorouracil-based chemotherapy, the frontline treatment of patients with nonsquamous non–small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma plus interferon alfa, and persistent, recurrent, or metastatic cervical cancer.
The application is supported by data from a series of preclinical comparison studies, clinical pharmacokinetic comparison studies, as well as an international multicenter phase 3 comparison study (NCT03329911), which showed that the biosimilar was similar to the reference product with regard to safety, efficacy, and immunogenicity. However, biosimilarity has yet to be established by regulatory authorities.
Under the Biosimilar Fee Act, the regulatory agency will make a decision on the product by November 27, 2021.
“The FDA’s acceptance of our BLA is a significant achievement that brings Bio-Thera closer to providing cancer patients in the United States with a high-quality, low-cost treatment option,” Shengfeng Li, PhD, founder and CEO of Bio-Thera Solutions, stated in the press release. “Regulatory filings for BAT1706 have now been accepted by the China National Medical Products Administration, European Medicines Agency, and FDA, demonstrating Bio-Thera’s commitment to developing BAT1706 to global standards so that BAT1706 can be made available to the global cancer patient community.”
In the multicenter, double-blind, phase 3 trial, investigators set out to examine the safety, efficacy, pharmacokinetics, and immunogenicity of BAT1706 compared with the European bevacizumab product plus chemotherapy in patients with advanced nonsquamous NSCLC.
To be eligible for the trial, patients needed to have stage IV nonsquamous NSCLC or recurrent disease, tumors without an activating EGFR or ALK mutations, at least 1 measurable target lesion per RECIST v1.1 criteria, an ECOG performance status of 0-1, and a life expectancy of more than 3 months per investigator assessment.2
If they had small cell carcinoma of the lung, mixed predominant squamous cell carcinoma of the lung, or NSCLC not otherwise specified, they were excluded. Moreover, if patients previously received treatment with monoclonal antibodies, VEGF/VEGFR small molecule inhibitors, or systemic therapy for metastatic disease, they could not participate.
In the trial, patients on the investigational arm received intravenous (IV) BAT1706 at a dose of 15 mg/kg given every 3 weeks of a cycle for up to 6 cycle. Those who did not progress received maintenance monotherapy with the biosimilar for up to 8 months maximum. These patients also received IV paclitaxel at a dose of 200 mg/m2 every 3 weeks of a cycle for up to 6 cycles and carboplatin AUC 6.0 mg/mL per minute very 3 weeks of a cycle for up to 6 cycles. Those in the control arm received IV European bevacizumab at a dose of 15 mg/kg every 3 weeks for up to 6 cycles.
In February 2020, topline data from the trial showed that the overall response rate elicited by the biosimilar was equivalent to that of the reference product when evaluated in patients with NSCLC, thus meeting the primary end point of the study.3