Genentech: Subcutaneous Perjeta/Herceptin Combo Comparable to IV
December 12 2019 - 11:44AM
Dow Jones News
By Colin Kellaher
Roche Holdings AG's (ROG.EB) Genentech unit on Thursday said a
fixed-dose combination of Perjeta and Herceptin administered by
subcutaneous injection showed non-inferior pharmacokinetics and
comparable efficacy and safety to standard intravenous infusions
while significantly reducing the time spent receiving treatment in
patients with HER2-positive early breast cancer.
Genentech said the study met its primary endpoint, with
subcutaneous administration of the combination showing non-inferior
levels of Perjeta in the blood when compared to IV administration
of Perjeta.
A secondary endpoint of non-inferior levels of Herceptin was
also met.
Genentech said subcutaneous administration of the combination
takes about eight minutes for the initial loading dose and roughly
five minutes for subsequent maintenance doses, compared with 150
minutes for infusion of a loading dose of Perjeta and Herceptin
using the standard IV formulations, and 60 to 150 minutes for
subsequent infusions.
Genentech, which noted that the new subcutaneous formulation
combines Perjeta and Herceptin with Halozyme Therapeutics Inc.'s
(HALO) Enhanze drug-delivery technology, said it plans to submit
the study data to health authorities around the world, including
the U.S. Food and Drug Administration and European Medicines
Agency.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 12, 2019 11:29 ET (16:29 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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