The FDA approved subcutaneous Phesgo – a combination of pertuzumab (Perjeta), trastuzumab (Herceptin), and hyaluronidase–zzxf – for the treatment of patients with metastatic HER2-positive breast cancer, as well as early-stage HER2-positive breast cancer, as selected by an FDA-approved companion diagnostic test.
Of note, the drug can be delivered at home by a healthcare professional.
“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, M.D., 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, in a statement.
Phesgo contains fixed-dose of all 3 drugs, with the same therapeutic components as those in FDA-approved indications of IV pertuzumab and trastuzumab.
The approval was based on the results of a non-inferiority study that involved patients with early-stage HER2-postrivie breast cancer. Phesgo had comparable efficacy and safety as when each of the drugs are given via IV.
There is a boxed warning on Phesgo, advising nurses and other providers to monitor patients for heart failure, fetal harm, and lung toxicity. If a patient experiences anaphylaxis or sever hypersensitivity, they should discontinue Phesgo.
Common adverse events (AEs) for Phesgo included hair loss, nausea, diarrhea, anemia, and asthenia. The drug can also cause worsening of chemotherapy-induced neutropenia. Additionally, since the drug may cause harm to a developing fetus or newborn baby, the FDA recommends professionals to discuss the fact that exposure to Phesgo during pregnancy or within 7 months prior to conception may result in fetal harm.
“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. At this critical time, we continue to expedite oncology product development. This application was approved about four months ahead of the FDA goal date,” Pazdur said.