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Amgen Files for Xgeva Label Expansion, To Include Myeloma
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Amgen, Inc. (AMGN - Free Report) recently announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the label of its key drug, Xgeva.
Xgeva is currently approved for the prevention of skeletal-related events (SREs) in solid tumors in patients with bone metastases. Amgen is looking to expand the label to include patients with multiple myeloma.
The company has also submitted an application to modify the marketing authorization to the European Medicines Agency (EMA).
The sBLA was based on data from a head-to-head phase III study conducted internationally. The study, which compared Xgeva to Novartis AG’s (NVS - Free Report) Zometa (zoledronic acid), met the primary endpoint of non-inferiority of the drugs in delaying of the time to first on-study SRE in patients with multiple myeloma. The secondary endpoints involved assessing the superiority of XGEVA versus zoledronic acid regarding delaying the time to first on-study SRE and delaying time to first-and-subsequent SRE of the study. The overall survival (OS) was in favour of Xgeva, albeit statistically insignificant. The progression-free survival (PFS) rate improved by 10.7 months when treated with Xgeva versus Zometa.
Amgen’s share price movement shows that the stock has outperformed the Zacks classified Medical - Biomedical and Genetics industry so far this year. Amgen’s stock gained 12.4% during this period, while the industry registered an increase of 3.3%.
Multiple myeloma is the second most common hematologic cancer that develops in plasma cells in the bone marrow. According to the study, Estimated Cancer Incidence, Mortality and Prevalence, multiple myeloma affects nearly 114,000 new patients worldwide and results in 80,000 deaths every year.
Bisphosphonates are the only treatment option available to multiple myeloma patients at present. However, it may cause renal toxicity and lead to renal impairment. The company expects Xgeva to offer a novel way of treatment.
Xgeva is key revenue driver for Amgen and generated revenues of $1.53 billion in 2016, up 9% year over year. We expect approval for the expanded label to help in further boosting sales of the drug.
Zacks Ranks & Picks
Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and Grifols, S.A. (GRFS - Free Report) . Grifols sports a Zacks Rank #1 (Strong Buy), while Vertex carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Vertex have gained 52.4% this year so far, while the company’s earnings estimates for 2017 have gone up by almost 4% in the past 60 days.
Grifols’ earnings per share estimates have increased from $1.04 to $1.14 for 2017 over the last 60 days. The company’s shares appreciated18.1% in the past one year.
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Amgen Files for Xgeva Label Expansion, To Include Myeloma
Amgen, Inc. (AMGN - Free Report) recently announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the label of its key drug, Xgeva.
Xgeva is currently approved for the prevention of skeletal-related events (SREs) in solid tumors in patients with bone metastases. Amgen is looking to expand the label to include patients with multiple myeloma.
The company has also submitted an application to modify the marketing authorization to the European Medicines Agency (EMA).
The sBLA was based on data from a head-to-head phase III study conducted internationally. The study, which compared Xgeva to Novartis AG’s (NVS - Free Report) Zometa (zoledronic acid), met the primary endpoint of non-inferiority of the drugs in delaying of the time to first on-study SRE in patients with multiple myeloma. The secondary endpoints involved assessing the superiority of XGEVA versus zoledronic acid regarding delaying the time to first on-study SRE and delaying time to first-and-subsequent SRE of the study. The overall survival (OS) was in favour of Xgeva, albeit statistically insignificant. The progression-free survival (PFS) rate improved by 10.7 months when treated with Xgeva versus Zometa.
Amgen’s share price movement shows that the stock has outperformed the Zacks classified Medical - Biomedical and Genetics industry so far this year. Amgen’s stock gained 12.4% during this period, while the industry registered an increase of 3.3%.
Multiple myeloma is the second most common hematologic cancer that develops in plasma cells in the bone marrow. According to the study, Estimated Cancer Incidence, Mortality and Prevalence, multiple myeloma affects nearly 114,000 new patients worldwide and results in 80,000 deaths every year.
Bisphosphonates are the only treatment option available to multiple myeloma patients at present. However, it may cause renal toxicity and lead to renal impairment. The company expects Xgeva to offer a novel way of treatment.
Xgeva is key revenue driver for Amgen and generated revenues of $1.53 billion in 2016, up 9% year over year. We expect approval for the expanded label to help in further boosting sales of the drug.
Zacks Ranks & Picks
Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and Grifols, S.A. (GRFS - Free Report) . Grifols sports a Zacks Rank #1 (Strong Buy), while Vertex carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Vertex have gained 52.4% this year so far, while the company’s earnings estimates for 2017 have gone up by almost 4% in the past 60 days.
Grifols’ earnings per share estimates have increased from $1.04 to $1.14 for 2017 over the last 60 days. The company’s shares appreciated18.1% in the past one year.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>