Genentech Says FDA Approves Herceptin Hylecta for Some Breast Cancer Patients

   By Stephen Nakrosis 
 

Genentech on Thursday said the U.S. Food and Drug Administration approved Herceptin Hylecta to treat certain patients with breast cancer.

The new approval allows the subcutaneous injection of Herceptin Hylecta in certain patients, either in combination with chemotherapy drugs or alone in people who have received one or more chemotherapy regimens for metastatic disease.

Herceptin Hylecta is a ready-to-use formulation that can be administered in two minutes to five minutes, compared to 30 minutes to 90 minutes for intravenous Herceptin, the company said.

The FDA approval is based on results from three clinical studies in Human Epidermal growth factor Receptor 2-positive early breast cancer, the company said.

Biotech company Halozyme Therapeutics Inc. (HALO) said Herceptin Hylecta is the third product co-formulated with that company's Enhanze drug-delivery technology to receive FDA approval.

Genentech is a member of the Roche Group.

Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

February 28, 2019 12:13 ET (17:13 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.