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Roche’s Avastin Gets Full FDA Approval for Brain Cancer

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Roche Holding AG’s RHHBY member, Genentech announced that the FDA has converted accelerated approval for Avastin (received in May 2009) for previously treated glioblastoma, most aggressive form of brain cancer, to full approval.

The full approval was based on data from the phase III EORTC 26101study in which Avastin-based treatment increased the time to disease progression or death compared to chemotherapy alone. The study, however, did not meet the primary endpoint as there was no significant increase in overall survival with Avastin-based treatment.

However, it showed that patients were able to completely stop intake of corticosteroids while on treatment in the Avastin arm compared to the control arm. The evidence from the study, which showed that Avastin treatment delayed disease progression and reduced the need for corticosteroids, led to the conversion of the provisional approval to a full one.

Apart from the recent approval, the drug is already approved in the United States for various indications that include- first- or second-line treatment of metastatic colorectal cancer, advanced nonsquamous non–small cell lung cancer (NSCLC), metastatic kidney cancer and advanced cervical cancer and recurrent ovarian cancer.


So far this year, shares of the company have increased 8.4% compared with the industry’s gain of 15%.

However, the drug has been facing competition and has been witnessing declining sales. In September 2017, Amgen AMGN and its partner Allergan AGN announced that the FDA approved their biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer. The biosimilar to be marketed by the trade name Mvasi is the first cancer biosimilar approved in the United States. It is also the first biosimilar for Avastin in the same country.

Zacks Rank & Stocks to Consider

Roche carries a Zacks Rank #4 (Sell). A top ranked health care stock in the same space is Johnson and Johnson JNJ sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Johnson and Johnson’s earnings per share estimates have moved up from $7.18 to $7.28 for 2017 and from $7.72 to $7.85 for 2018, over the last 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 3.12%. The share price of the company has increased 21.2% year to date.

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