Roche Holdings Ltd. (RHHBY) recently announced that its Biologics License Application (BLA) for pertuzumab has been accepted by the US Food and Drug Administration (FDA) for review. The regulatory body has granted priority review status to the company’s application, which seeks to get pertuzumab approved in combination with Herceptin (trastuzumab) and chemotherapy docetaxel for treatment-na?ve and treatment-experienced HER2-positive metastatic breast cancer (mBC) patients.
The FDA’s decision on the BLA is expected by June 8, 2012.
Roche’s application is based on results from a late-stage study, CLEOPATRA. The study evaluated the safety and efficacy of pertuzumab combined with Herceptin and chemotherapy, compared to Herceptin and docetaxel alone in 808 people with previously untreated HER2-positive mBC.
The study demonstrated that patients dosed with the combination drug experienced median progression-free survival (primary endpoint) of 18.5 months, compared to 12.4 months in patients who received only Herceptin and docetaxel.
Roche also has a Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) for pertuzumab for treatment-na?ve patients with HER2-positive mBC.
We note that Roche currently markets Herceptin as a treatment for HER2-positive breast cancer and advanced HER2-positive stomach cancer. Other treatments in the market for the treatment of HER2-positive breast cancer include GlaxoSmithKline‘s (GSK) Tykerb.
It has been a good year so far for Roche, where its pipeline is concerned. In January, the FDA approved its skin cancer drug Erivedge (vismodegib) for the treatment of patients with advanced basal cell carcinoma (BCC). The once-daily oral drug is approved for use in patients whose cancer has relapsed after surgery or whose cancer has spread to other parts of the body or who cannot be treated with surgery or radiation.
We believe that such positive developments at regular intervals on the pipeline front will help Roche’s long-term growth.
We currently have a Zacks #3 Rank (short-term Hold rating) on the company.
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