Posted by Michael Wonder on 21 Dec 2017
FDA approves Genentech’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer
20 December 2017 - Accelerated approval of Perjeta for neo-adjuvant use also converted to full approval.
Genentech today announced the U.S. FDA has approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles).
The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive). People receiving the neoadjuvant Perjeta-based regimen should continue Perjeta and Herceptin after surgery to complete one year of treatment.
The FDA-approved use of the Perjeta-based regimen for adjuvant treatment of HER2-positive EBC at high risk of recurrence is based on results of the Phase III APHINITY study.
