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Genentech Garners FDA Approval for Skin-Injectable Phesgo in HER2-Positive Breast Cancer

NEW YORK – The US Fsood and Drug Administration today approved a new combination treatment from Genentech for HER2-positive metastatic breast cancer that may be administered to patients in their homes by a qualified healthcare professional.

The treatment (Phesgo) contains fixed doses of two Genentech drugs, pertuzumab (Perjeta) and trastuzumab (Herceptin), and hyaluronidase, and is meant to be given in combination with intravenous chemotherapy. Once the intravenous chemo portion of the cocktail is finished, the pertuzumab/trastuzumab/hyaluronidase regimen can be administered via injection under the skin at a treatment center or in patients' homes.

Patients eligible for the treatment must have HER2 overexpressing breast cancer as determined by an FDA-approved companion test.

"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," Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in a statement announcing the drug's approval.

The availability of drugs that can be taken at home without having to come into a healthcare facility is particularly important during the COVID-19 pandemic. Cancer patients receiving chemotherapy have weakened immune systems and are particularly vulnerable to infection.

"As part of the FDA's ongoing commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease," Pazdur said, adding that the application for this new treatment was approved four months before the agency was slated to issue a decision.  

The agency approved the new regimen based on the results of a Phase III non-inferiority study, called FeDeriCa, that showed that safety and efficacy of the injection version of the pertuzumab/trastuzumab/hyaluronidase combo was largely comparable to pertuzumab/trastuzumab given intravenously. The subcutaneous version resulted in more administration-related reactions than the intravenous regimen. Common side effects with pertuzumab/trastuzumab/hyaluronidase included hair loss, nausea, diarrhea and anemia, and reduced white blood cell count.

In a statement announcing the approval of this new option for HER2-positive breast cancer, Genentech highlighted that the injected regimen takes around eight minutes to administer the loading dose, and five minutes for each maintenance dose. In comparison, the intravenous administration of pertuzumab and trastuzumab takes 150 minutes for the loading dose, and between 60 minutes and 150 minutes for maintenance infusions.

In the 160-patient Phase II PHranceSCa study, 85 percent of patients receiving treatment for HER2-positive breast cancer preferred receiving pertuzumab and trastuzumab via injections over the intravenous route, finding it less time consuming and more comfortable.

"Phesgo offers a treatment administration that supports the needs and preferences of individual patients and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options," Levi Garraway, executive VP and head of product development at Genentech, said in a statement.