Combo HER2 Product Recommended for Approval in EU

Roxanne Nelson, RN, BSN

November 16, 2020

The new combination product of pertuzumab with trastuzumab together with hyaluronidase (Phesgo, Roche), which can be administered by subcutaneous injection, has been recommended for approval in the European Union. The indication is early and metastatic breast cancer.

This product is already available in the United States, having been approved by the Food and Drug Administration (FDA) in June.

The new formulation allows for subcutaneous administration at home, whereas the component drugs — both HER2 targeted agents — are usually administered by intravenous infusion in a clinic/hospital setting.  

This is the unique aspect of this product, the FDA noted when announcing the drug's approval: it can be administered in a patient's home by a qualified healthcare professional once chemotherapy has been completed.

"Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an outpatient option for patients to receive trastuzumab and pertuzumab," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research.

The recommendation for approval in the EU was made by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

It notes that for early breast cancer, the indication is for Phesgo to be used in combination with chemotherapy in the neoadjuvant setting, in patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence. The other indication is as adjuvant treatment in HER2-positive early breast cancer at high risk of recurrence.

For metastatic disease, Phesgo is to be used in combination with docetaxel (Taxotere) in HER2-positive metastatic or locally recurrent unresectable breast cancer, and in patients who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Tagraxofusp Recommended 

The CHMP also reversed a previous decision on an agent for use in a rare leukemia, and has now recommended approval in the EU for tagraxofusp (Elzonris, Stemline Therapeutics).

The indication is for first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive type of acute myeloid leukemia.

The recommendation for approval was based on results from a study that involved 13 treatment naive patients. Treatment with tagraxofusp led to a complete response rate of 53.8% in that population.

The committee had initially refused the application in July for tagraxofusp to be used for the treatment of BPDCN regardless of whether patients had been previously treated or were treatment naive. After re-examination, the CHMP has now recommended that marketing authorization under exceptional circumstances could be granted — but for a restricted indication, to be used as first-line treatment only.

Tagraxofusp is comprised of a truncated diphtheria toxin fusion protein linked with recombinant human interleukin-3 (IL 3) to target CD123-expressing cells. It irreversibly inhibits protein synthesis of target cells by inactivating elongation factor 2 (EF2), resulting in apoptosis.

The most common side effects observed with tagraxofusp include hypoalbuminemia, increased transaminases, thrombocytopenia, nausea, fatigue, and pyrexia observed in >20% of patients. The most serious adverse event that has occurred is capillary leak syndrome, which was reported in 17% of patients with a median time to onset of 6 days.

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