Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with docetaxel for the treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

This is written in the approval document as:

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for use in combination with docetaxel for treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Citation

Genentech, Inc. Phesgo (pertuzumab and trastuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf. Revised June 2020. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Docetaxel, Pertuzumab, Trastuzumab