The Food and Drug Administration (FDA) on June 29 approved Phesgo, a treatment for breast cancer that can be administered at home by healthcare professionals.
Phesgo is a fixed dose combination of two monoclonal antibodies and allows the treatment of both early and metastatic HER2 positive breast cancer for outpatients. The two monoclonal antibodies are pertuzumab, trastuzumab and the combination also includes hyaluronidase, a substance that is injected into the patient to increase drug absorption. The approval of the treatment has been granted to Genentech Inc.
The FDA claimed that HER2 positive breast cancer makes up about a fifth of breast cancer cases and occurs due to an excess of a protein called epidermal growth factor receptor 2 (HER2) that promotes the growth of cancer cells.
“Pertuzumab and trastuzumab bind to HER2 sites and stop signaling to stop tumor cell growth,”
Dr. Richard Pazdur, director of the FDA’s Center of Cancer Excellence and interim director of the FDA’s Office of Oncologic Diseases and Evaluation and Research on Drugs Research, said that currently most patients currently receive pertuzumab and trastuzumab in their infusion centers.
“With a new route of administration, Phesgo offers an outpatient option for patients to receive trastuzumab and pertuzumab,” said Pazdur in a statement adding that health authorities focus heavily on patients with cancer as they are also vulnerable to CCP, also called the novel coronavirus.
“At this critical moment, we continue to accelerate the development of the cancer product. This application was approved approximately four months before the FDA’s target date, “he said.
FDA officials said administration approval for Phesgo came after a non-inferiority study in HER2-positive early-stage breast cancer patients. Non-inferiority test Test to see if a new experimental treatment is less effective than an existing one.
The treatment has some side effects: hair loss, nausea, diarrhea, anemia and lack of energy. “Phesgo can cause chemotherapy-induced neutropenia (low white blood cell level) to worsen,” the FDA said.
Officials warned pregnant women that Phesgo can cause harm to a developing fetus or newborn baby. “The FDA advises healthcare professionals to inform women of reproductive age that exposure to Phesgo during pregnancy or within 7 months before conception can cause harm to the fetus,” said the FDA.
Officials also informed that patients with anaphylaxis or severe allergic reaction or severe hypersensitivity should stop Phesgo.