(EC) Roche Holdings Gets FDA Panel View on Avastin

Roche Holdings Ltd. (RHHBY) recently announced that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended that the agency should withdraw its approval for the use of Avastin (bevacizumab) in combination with paclitaxel in previously untreated (first-line) HER2-negative metastatic breast cancer. The FDA Commissioner will take a final call on this matter.

However, the recommendation is not expected to impact other indications of the drug. Avastin is approved in the US for treating other types of cancer and in other countries for treating metastatic breast cancer.

Recently, the company also announced that the European Commission (EC) has 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.

We note that the drug is already available in the European Union (EU) in combination with Xeloda (capecitabine) as a first-line treatment for metastatic breast cancer.

The EC’s approval was based on positive data from the late-stage RIBBON 1 study. The study data demonstrated that women who were dosed Avastin in combination with Xeloda experienced a higher period of progression-free survival, as compared to patients who received only Xeloda.

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.

Moreover, Roche markets Xeloda worldwide as a treatment for breast cancer, colorectal cancer and stomach cancer.

We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.

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