Breaking News
admin
Feb 22 2025
1The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for HLX11, a pertuzumab biosimilar, for the treatment of HER2-positive (HER2+) breast cancer. The acceptance brings a potential cost-effective alternative closer to approval, addressing the need for accessible biologic therapies in oncology.
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Clinical Trial Highlights
The BLA submission was supported by a randomized, double-blind clinical trial that assessed the efficacy, safety, and pharmacokinetics of HLX11 compared to reference pertuzumab.
Patient Selection Criteria
HER2+ Breast Cancer Diagnosis: Tumors with less than 1% nuclear staining for estrogen and progesterone receptors.
Key Inclusion Criteria:
Baseline left ventricular ejection fraction (LVEF) ≥ 55%.
Adequate major organ function.
Exclusion Criteria:
Inflammatory breast cancer.
Stage IV, bilateral, or multicentric breast cancer.
History of other malignancies within the past 5 years, except for specific cases like treated cervical carcinoma in situ or certain skin cancers.
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Treatment Protocol
Patients were randomized (1:1) to receive HLX11 or reference pertuzumab combined with trastuzumab and docetaxel:
Neoadjuvant Phase (Pre-Surgery):
HLX11 or pertuzumab:
Loading dose: 840 mg.
Maintenance dose: 420 mg every 3 weeks (up to 4 cycles).
Trastuzumab:
Loading dose: 8 mg/kg.
Maintenance dose: 6 mg/kg every 3 weeks.
Docetaxel: 75 mg/m² every 3 weeks.
Adjuvant Phase (Post-Surgery):
HLX11 or pertuzumab:
Loading dose: 840 mg.
Maintenance dose: 420 mg every 3 weeks (up to 13 cycles).
Trastuzumab:
Loading dose: 8 mg/m².
Maintenance dose: 6 mg/m² every 3 weeks (up to 13 cycles).
Chemotherapy:
Doxorubicin (60 mg/m²) and cyclophosphamide (600 mg/m²) every 3 weeks for 4 cycles.
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Primary and Secondary Endpoints
Primary Endpoint: Pathologic complete response (pCR) rate, measuring the absence of invasive cancer in the breast and lymph nodes post-treatment.
Secondary Endpoint: Breast pCR rate, focusing solely on breast tissue response.
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Significance of HLX11 Approval
If approved, HLX11 would expand access to pertuzumab-based therapies, potentially reducing treatment costs without compromising clinical outcomes. Pertuzumab, combined with trastuzumab and chemotherapy, remains a standard of care for HER2+ breast cancer, significantly improving survival rates.
The FDA’s acceptance of the BLA signals confidence in HLX11’s ability to deliver comparable efficacy and safety, marking a potential turning point in the availability of life-saving oncology treatments.
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About HER2-Positive Breast Cancer:
HER2-positive breast cancer is characterized by the overexpression of the HER2 protein, leading to aggressive tumor growth. Targeted therapies like pertuzumab have dramatically improved treatment outcomes, particularly in combination with trastuzumab and chemotherapy.
Source: https://www.letlifehappen.com/fda-accepts-bla-for-pertuzumab-biosimilar-in-her2-breast-cancer/
