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news.Genentech, a member of Roche group, has received Biologics License Application and Priority Review acceptance for Pertuzumab by the US Food and Drug Administration (FDA).
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Pertuzumab, a HER2 dimerization inhibitor is designed specifically to prevent the HER2 receptor from with other HER receptors, thereby inhibiting the growth and formation of tumor.
The proposed indication is Pertuzumab in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable breast cancer.
The application is based on results from the pivotal Phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) study that demonstrated a 6.1 month improvement in median progression-free survival (PFS).
Roche has also submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for Pertuzumab as a treatment for HER2-positive metastatic breast cancer (mBC).