Roche Holdings Ltd. (RHHBY) recently reported positive data from a late-stage study, CLEOPATRA, which investigated a combination treatment involving pertuzumab and Herceptin (trastuzumab). The study evaluated the safety and efficacy of pertuzumab combined with Herceptin and chemotherapy docetaxel, compared to Herceptin and docetaxel alone in 808 people with previously untreated HER2-positive metastatic breast cancer (mBC).
The study demonstrated that patients dosed with the aforementioned combination 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 is seeking to get the combination drug approved as a treatment for HER2-positive mBC and has filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA). It has also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for the same.
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.
Another of Roche’s mBC treatments, Avastin (bevacizumab), was recently in news when the FDA annulled the approval of the drug for use in the US as a treatment for mBC. The regulatory body believes that Avastin is not safe and effective to be used for the said indication.
However, the FDA's decision to revoke the US approval of Avastin is not applicable for other approved indications of the drug. The decision also does not impact the use of Avastin in other countries for mBC or other indications.
Apart from breast cancer, Avastin is marketed worldwide for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma (brain cancer) and renal cell carcinoma (kidney cancer).
In the short run, we have a Zacks #4 Rank (Sell rating) on Roche.
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