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Perjeta Approval Heralds Roche’s Next Wave Of Breast Cancer Drugs

 
• By Emily Hayes

Genentech pledges to make new HER2-positive drug Perjeta (pertuzumab) available in the U.S. in two weeks, addresses FDA concerns about production issues and a potential shortage. Firm is already moving forward with plans for integrating Perjeta into its breast cancer portfolio, including combination with antibody-drug conjugate T-DM1.

The FDA approval ofRoche/Genentech Inc.’s Perjeta (pertuzumab) launches the next wave of the company’s HER2-positive breast cancer franchise, but take-off will be limited by production difficulties.

An intravenously delivered monoclonal antibody, the drug was approved for use in combination with the company’s HER2-targeting Herceptin (trastuzumab) and chemotherapy in previously untreated HER2-positive metastatic breast cancer that has recurred after adjuvant or neoadjuvant therapy, Genentech announced late June 8

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