The U.S. Food and Drug Administration (FDA) has approved Poherdy (pertuzumab-dpzb) as the first interchangeable biosimilar to Perjeta (pertuzumab) for patients with HER2-positive breast cancer. This approval represents a significant advance in expanding access to targeted therapies for this aggressive form of breast cancer.
According to the American Cancer Society, biosimilars are highly similar versions of existing biologic drugs that offer comparable safety and effectiveness. While not exact copies, they must meet strict FDA standards. Biosimilars can improve access to essential treatments while potentially reducing healthcare costs.
Indications and Uses of Poherdy
Poherdy is a HER2/neu receptor antagonist approved for multiple treatment settings in adults with HER2-positive breast cancer:
Metastatic setting: Combined with Herceptin (trastuzumab) and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior chemotherapy or anti-HER2 therapy for metastatic disease.
Neoadjuvant therapy: Used with Herceptin and chemotherapy before surgery for locally advanced, inflammatory, or early-stage HER2-positive breast cancer larger than 2 centimeters or with lymph node involvement.
Adjuvant therapy: Administered after surgery to reduce the risk of recurrence in adults with high-risk early-stage HER2-positive breast cancer.
Glossary:
Adjuvant therapy: Treatment given after primary therapy (like surgery) to eliminate remaining cancer cells.
Neoadjuvant therapy: Treatment given before primary therapy to shrink tumors.
Clinical Evidence Supporting Approval
The FDA’s decision was based on clinical data demonstrating that Poherdy and Perjeta are equivalent in pharmacokinetics, immunogenicity, and clinical outcomes, confirming Poherdy’s interchangeability.
The approval also relies on prior research with Perjeta, including the CLEOPATRA trial, which evaluated Perjeta in combination with Herceptin and docetaxel as first-line therapy for untreated HER2-positive metastatic breast cancer. Participants received Perjeta or placebo alongside standard therapy, with treatment continuing until disease progression or unacceptable side effects.
Additional evidence came from the APHINITY trial, a phase 3 study examining Perjeta plus chemotherapy and Herceptin as adjuvant therapy for operable HER2-positive breast cancer. The trial demonstrated a reduction in recurrence risk when Perjeta was added to standard therapy. These studies helped establish the therapeutic relevance of Perjeta and its biosimilar, Poherdy, across multiple disease stages.
Safety Profile and Administration
Poherdy carries a boxed warning for potential left ventricular dysfunction (heart problems) and embryo-fetal toxicity, consistent with other HER2-targeted agents. Other possible side effects include infusion reactions, hypersensitivity, and anaphylaxis. Patients should be closely monitored for cardiac function and adverse infusion events.
The recommended dosing schedule is an initial 840 mg intravenous infusion over 60 minutes, followed every three weeks by 420 mg infused over 30 to 60 minutes. Full prescribing information will be available through the FDA database to guide safe and effective use.
Expanding Access to Targeted Treatments
As the first interchangeable biosimilar to Perjeta, Poherdy can be substituted without prescriber intervention, which may increase affordability and accessibility for patients with HER2-positive breast cancer. With approvals across metastatic, neoadjuvant, and adjuvant settings, Poherdy offers clinicians an additional option for tailoring treatment strategies to individual patient needs.
This approval underscores ongoing efforts to broaden access to advanced therapies, potentially improving outcomes for patients living with HER2-positive breast cancer.
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