Roche Holdings Ltd. (RHHBY) recently announced that the European Commission has approved its cancer drug Zelboraf, which is to be used as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive metastatic melanoma (skin cancer).
The approval did not come as a surprise, as in December last year the Committee for Medicinal Products for Human Use (CHMP) had recommended the approval of the drug for the said indication.
Zelboraf was recently approved in a number of countries including Switzerland, Brazil, Israel, Canada and New Zealand. Moreover, Zelboraf is currently under review in Australia, India and other countries.
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 has been acquired by Daiichi Sankyo, the diagnostic test was solely developed by Roche.
We note that Roche has continuously been in the news lately. Earlier this month, the FDA accepted the company’s Biologics License Application (BLA) for pertuzumab for review. The regulatory body granted priority review status to Roche’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. Additionally, Roche has a Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) that is seeking approval of pertuzumab for treatment-na?ve patients with HER2-positive mBC.
We believe that such positive developments at regular intervals on the pipeline front will help the company’s long-term growth trajectory.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
