We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche's (RHHBY) Avastin Gets Label Expansion Approval by FDA
Read MoreHide Full Article
Roche (RHHBY - Free Report) 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 - Free Report) 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.
Some better-ranked stocks from the same space are Illumina, Inc. (ILMN - Free Report) and Aeglea BioTherapeutics, Inc. . 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.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia and other conditions. New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Image: Bigstock
Roche's (RHHBY) Avastin Gets Label Expansion Approval by FDA
Roche (RHHBY - Free Report) 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 - Free Report) 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.
Roche Holding AG Price
Roche Holding AG Price | Roche Holding AG Quote
Zacks Rank
Roche has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Illumina, Inc. (ILMN - Free Report) and Aeglea BioTherapeutics, Inc. . 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.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia and other conditions. New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>