Roche Holding AG (ROG.EB) said on Thursday that the U.S. Food and Drug Administration has approved Perjeta in combination with other treatments for after-surgery treatment of certain types of breast cancer.
Following the FDA's decision, the Perjeta-based regimen is now approved for the post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence.
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The Perjeta-based regimen is a combination of Perjeta, chemotherapy and Herceptin, another Roche cancer drug. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, Roche said, to prevent tumor cell growth and survival.
The regimen had previously been granted FDA approval for HER2-positive metastatic breast cancer as well as accelerated approval for pre-surgery use in patients with early stage breast cancer. Roche said that its accelerated approval for the pre-surgery use of the Perjeta-based regimen has now been converted to a full approval.
"Today's approval of Perjeta means people with HER2-positive early breast cancer at high risk of recurrence have a new, clinically meaningful treatment option to reduce the chances of their disease returning," said Sandra Horning, Roche's chief medical officer and head of global product development.
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(END) Dow Jones Newswires
December 21, 2017 02:09 ET (07:09 GMT)