Roche Holdings Ltd. (RHHBY) announced that the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Avastin (bevacizumab) in combination with standard chemotherapy (carboplatin and paclitaxel), as a front-line treatment for advanced ovarian cancer. The final decision from the European Commission is expected later in 2011.
We note that in late-stage studies (GOG0218 and ICON7), Avastin demonstrated that patients who received Avastin in combination with chemotherapy and then continued on Avastin alone, experienced a significantly longer progression-free survival, compared to those who received chemotherapy only.
In June, the European Commission (EC) approved Avastin to be used in combination with Xeloda (capecitabine) as a first-line treatment for metastatic breast cancer in women for whom treatment with other chemotherapies is considered inappropriate.
Roche markets Xeloda worldwide as a treatment for breast cancer, colorectal cancer and stomach cancer.
In the same month, the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended the regulatory body to withdraw its approval for the use of Avastin in combination with paclitaxel in treatment-naïve patients with HER2-negative metastatic breast cancer. The FDA Commissioner is due to take a final call on this matter.
However, we note that the recommendation is not expected to impact other indications of the drug. Avastin, which is currently marketed worldwide for the treatment of colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC), kidney cancer and glioblastoma (a type of brain cancer), faces competition from Eli Lilly & Co.’s (LLY) Erbitux.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
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