Roche’s Avastin’s Label Expanded in EU for Cervical Cancer

Roche Holding AG RHHBY received positive news when the European Commission approved yet another label expansion of its oncology drug Avastin.

Avastin is now approved in Europe in combination with standard chemotherapy (either paclitaxel and cisplatin or paclitaxel and topotecan in patients who cannot receive platinum therapy) for the treatment of adult patients suffering from persistent, recurrent or metastatic carcinoma of the cervix.

An approval was already on the cards as the Committee for Medicinal Products for Human Use issued a positive opinion on the use of Avastin in the aforementioned indication.

Approval in the EU was based on positive results from the GOG-0240 study, wherein women who received Avastin plus chemotherapy showed a statistically significant 26% reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone.

We note that the FDA approved Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy in Aug 2014 for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.

We remind investors that Avastin is already approved in Europe for the treatment of advanced stages of breast, colorectal, non-small cell lung, kidney and ovarian cancers. In the U.S., Avastin is approved for the treatment of colorectal, non-small cell lung, kidney, cervical and ovarian cancers. Moreover, the drug is approved in the U.S. for progressive glioblastoma following prior therapy.

We note that Avastin is one of the leading drugs in Roche’s portfolio. It generated sales of CHF6.4 billion in 2014, up 6% year over year. The oncology portfolio looks solid as ever and we expect further traction in 2015. We are encouraged by Roche's efforts on expanding the drug’s label, which should further boost sales.

Roche currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Actavis plc ACT, Sucampo Pharmaceuticals SCMP and Valeant Pharmaceuticals VRX. All three carry a Zacks Rank #2 (Buy).

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