On June 29, the U.S. Food and Drug Administration (FDA) approved Phesgo, an injectable treatment for adults with HER2-positive breast cancer. However, the FDA recommends that patients should only be accepted for the treatment after an “FDA-approved companion diagnostic test.”
According to the agency’s press release, HER2-positive breast cancer comprises about 20 percent of breast cancers. Phesgo, which is a combination of separate drugs used to treat breast cancer, is typically used in conjunction with chemotherapy.
The FDA’s recent approval means that a qualified health professional may continue to administer Phesgo treatments at a patient’s home after chemotherapy is complete.
“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. “At this critical time, we continue to expedite oncology product development. This application was approved about four months ahead of the FDA goal date.”
The FDA’s approval was the result of a study that Phesgo was comparable as a treatment with IV pertuzumab and IV trastuzumab, but reactions from administering the medication were higher with Phesgo. A prior study also reports that 85 percent of people who received the new treatment preferred it due to its convenience and comfort.
“The fixed-dose combination of trastuzumab and pertuzumab offers a simpler, faster, and easier treatment experience for patients with HER2-positive breast cancer,” said Antoinette Tan, MD, MHSc, Chief of Breast Medical Oncology at Levine Cancer Institute in Charlotte, North Carolina.
Genentech, the producer of Phesgo, says that the administration of their treatment takes around eight minutes, compared to the 150 minutes of standard infusion treatments.
Still, Medscape Medical News reported in April that one group, the Community Oncology Alliance, disapproves of at-home cancer treatments.
“The Community Oncology Alliance fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns,” they said in a statement. “Many of the side effects caused by cancer treatment can have a rapid, unpredictable onset that places patients in incredible jeopardy and can even be life-threatening.”
The FDA says that common side effects include alopecia, nausea, diarrhea, anemia, and asthenia. The health regulatory agency also warns that women who are pregnant or within seven months of conception could cause fetal harm.