FDA approves cancer treatment that can be administered at home

June 30, 2020
2 min read

The U.S. Food and Drug Administration (FDA) has approved Phesgo – a combination of pertuzumab, trastuzumab and hyaluronidase – for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer, according to a press release from the agency.

The FDA said Phesgo is initially used in combination with chemotherapy. However, it could be administered at home by a qualified healthcare professional once the chemotherapy regimen is finished. Patients should be selected based on an FDA-approved companion diagnostic test, the FDA said.

HER2-positive breast cancer, which makes up approximately one-fifth of breast cancers, has too much of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Pertuzumab and trastuzumab bind to sites on HER2 and disrupt signaling to stop cancer cell growth. Phesgo contains a fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase for injection under the skin. The therapeutic components in Phesgo are the same as those in FDA-approved intravenous (IV) pertuzumab and IV trastuzumab.

The FDA’s approval was based on the results of a non-inferiority study in patients with HER2-positive early breast cancer, which demonstrated Phesgo had comparable efficacy and safety as IV pertuzumab and IV trastuzumab, except for administration-related reactions, which were higher with Phesgo due to the subcutaneous route of administration.

Prescribing information for Phesgo includes a boxed warning to advise healthcare professionals and patients about the risk of potential heart failure, fetal harm, and lung toxicity.

Visit the FDA for more news

About the Author

Sign up for Medical Laboratory Observer eNewsletters