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Roche’s (RHHBY) Avastin Gets Label Expansion Approval by FDA


Roche RHHBY announced that the FDA has approved the label expansion for its oncology drug Avastin (bevacizumab). The FDA approved Avastin in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection.

The approval is based on data from the phase III GOG-0218 study. The study showed that women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12 months in women who received chemotherapy alone.

Year to date, shares of the company have decreased 16.1% compared with the industry’s decline of 4.5%.

With this approval, Avastin is now approved for 10 distinct uses across six different types of cancer in the United States. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer, recurrent, platinum-resistant and platinum-sensitive ovarian cancer, and recurrent glioblastoma.

Avastin is one of the leading drugs in Roche’s portfolio. However, sales of Avastin fell 2% in the first quarter of 2018 due to increasing use of cancer immunotherapy medicines in lung cancer.

Stiff competition from biosimilars looms large for Avastin. Amgen AMGN obtained FDA approval for a biosimilar version of Avastin for treatment of five types of cancers including lung cancer, colorectal cancer, glioblastoma, renal cell carcinoma and cervix cancer. Entry of biosimilars of the key drug will adversely impact sales in 2018.

Zacks Rank

Roche has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Illumina, Inc. ILMN and Aeglea BioTherapeutics, Inc. AGLE. While Illumina sports a Zacks Rank #1 (Strong Buy), Aeglea carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have moved up from $4.60 to $4.86 for 2018 and from $5.34 to $5.60 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 23.17%. The stock has rallied 31.5% so far this year.

Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 86.5% so far this year.

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