The FDA has approved a new combination treatment for HER2-positive breast cancer administered at home by a health care professional. 

The drug, a combination of pertuzumab, trastuzumab, and hyaluronidase- zzxf should be administered to patients “based on an FDA-approved companion diagnostic test,” a release from the FDA said. According to the release, the treatment is injected under the patient’s skin and includes the same therapeutic components as IV pertuzumab and IV trastuzumab. 

“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an out-patient 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 approval came after a review of the results of a non-inferiority study comparing the treatment to IV pertuzumab and IV trastuzumab for patients with HER2-positive early breast cancer. The release from the FDA said the new treatment had comparable efficacy and safety, except for administration-related reactions, which were higher than the previously available options.

The treatment includes a boxed warning advising of a risk of potential heart failure, fetal harm, and lung cancer, according to the FDA, which said providers should use “similar monitoring parameters” to those used with the IV treatments. Among the most common side effects were alopecia, nausea, diarrhea, anemia, and asthenia. It can also cause a worsening of chemotherapy-induced neutropenia. 

In the release, Pazdur said that due to the COVID-19 pandemic, the FDA has kept its focus on those patients who are vulnerable to contracting the disease while expediting the development of new oncology products. He said the approval for Phesgo was advanced nearly four months ahead of its original goal date.