Genentech Says FDA Approves Herceptin Hylecta for Some Breast Cancer Patients
February 28 2019 - 12:28PM
Dow Jones News
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
February 28, 2019 12:13 ET (17:13 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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