Genentech, a member of the Roche Group, said FDA has accepted the company’s supplemental Biologics License Application and granted Priority Review for Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer.
FDA is expected to make a decision on approval by January 28, 2018. The sBLA is based on results of the phase III APHINITY study. A priority review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
The sBLA seeks to convert the current accelerated approval to full approval. In the U.S., the combination of Perjeta, Herceptin and docetaxel chemotherapy is currently available under accelerated approval for neoadjuvant treatment of people with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.
Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival. The safety of Perjeta in combination with doxorubicin-containing regimens has not been established. The safety of Perjeta administered for greater than six cycles for early-stage breast cancer has not been established.
Perjeta is approved for use in combination with Herceptin and docetaxel in people who have HER2-positive metastic breast cancer and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
APHINITY(Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomized, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy compared to Herceptin and chemotherapy as adjuvant therapy in 4,805 people with operable HER2-positive EBC.
The primary efficacy endpoint of the APHINITY study is invasive disease-free survival, which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, overall survival, disease-free survival and health-related quality of life.
The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places, the company said. Thus, the combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signaling pathways, thus preventing tumor cell growth and survival.
Perjeta is approved for use in combination with Herceptin and docetaxel in people who have HER2-positive metastic breast cancer and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
Perjeta is approved for use prior to surgery in combination with Herceptin and docetaxel chemotherapy in people with HER2-positive, locally advanced, inflammatory, or early stage (tumor is greater than two centimeters in diameter or node-positive) breast cancer.
