The U.S. Food and Drug Administration (FDA) has approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to pertuzumab (Perjeta). This is the first approval of a biosimilar for pertuzumab.
Pertuzumab-dpzb is a HER2/neu receptor antagonist indicated for the following:
- Use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
- Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.
- Use in combination with trastuzumab and chemotherapy as adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
The approval was based on comparisons across a broad range of structural and functional product quality attributes, including those known to impact safety and efficacy, human pharmacokinetic data, clinical immunogenicity data, and supportive clinical data in patients with breast cancer demonstrating that pertuzumab-dpzb is biosimilar to and interchangeable with pertuzumab.
The prescribing information includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, and warnings and precautions for infusion-related reactions and hypersensitivity reactions/anaphylaxis.
The recommended initial pertuzumab-dpzb dose is 840 mg administered as a 60-minute intravenous infusion, then followed every 3 weeks by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.
