Roche Holdings Ltd. (RHHBY) recently announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Zelboraf as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive metastatic melanoma (skin cancer).
The European Commission is expected to come out with a decision on the same in February 2012.
We note that Zelboraf was approved in the US in August 2011 for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma. The US Food and Drug Administration (FDA) also approved the cobas 4800 BRAF V600 mutation test to identify patients eligible for treatment with Zelboraf. While Roche has co-developed the drug with Plexxikon, which was recently acquired by Daiichi Sankyo, the diagnostic test was solely conducted by Roche.
Roche is also seeking approval of Zelboraf for the said indication in Australia, New Zealand, Brazil, India, Mexico, Canada and other countries.
Earlier this month, Roche reported positive data on another cancer candidate, pertuzumab. The late-stage study (CLEOPARTA) evaluated the safety and efficacy of pertuzumab combined with Herceptin (trastuzumab) 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 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.
In the short run, we have a Zacks #3 Rank (Hold rating) on Roche.
