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Pfizer's Sutent Label Expansion Gets Mixed FDA Committee View
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Pfizer, Inc. (PFE - Free Report) announced that an FDA advisory committee gave a mixed opinion regarding a regulatory application that was filed to expand the label of its cancer drug Sutent.
Sutent is presently marketed for the first-line treatment of advanced renal cell carcinoma (RCC).With the latest supplemental new drug application (sNDA), which was accepted by the FDA in May this year, Pfizer is looking to get the label extended to include use in patients with high-risk of RCC recurrence.
The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for Sutent for the expanded indication. The FDA is expected to give a response in January 2018.
The sNDA in the United States was filed on the basis of aphase III study (S-TRAC) evaluating Sutent as an adjuvant treatment in patients at high risk of recurrent RCC, following nephrectomy (surgical removal of the cancer-containing kidney). Full data presented in October last year showed that Sutent extended disease-free survival (DFS) by more than a year compared to placebo, resulting in an overall risk reduction of 24%.
An application for use in the same patient population is also under review in the EU.
Sutent generated sales of $529 million in the first half of 2016, down 6% year over year due to competitive pressure in the United States and EU. If approved for the expanded patient population, sales of the drug might improve. It is estimated that 60% of high-risk patients will have RCC recurrence.
Pfizer’s shares have underperformed the industry this year so far. The stock has returned 9.1% during this period, comparing unfavorably with an increase of 16.4% for the industry.
Shares of Novartis are up 17.7% year to date. The Zacks Consensus Estimate for 2017 and 2018 climbed 0.4% and 1.2%, respectively, over the past 60 days.
Novo Nordisk’s shares up 35.7% this year so far. Its estimates have moved up 3.1% for 2017 while that for 2018 have increased 2.9% over the past 60 days.
Bayer’s stock is up 27.1% this year. Its estimates have moved up 4.1% for 2017 while that for 2018 have increased almost 1% over the past 60 days.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
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Pfizer's Sutent Label Expansion Gets Mixed FDA Committee View
Pfizer, Inc. (PFE - Free Report) announced that an FDA advisory committee gave a mixed opinion regarding a regulatory application that was filed to expand the label of its cancer drug Sutent.
Sutent is presently marketed for the first-line treatment of advanced renal cell carcinoma (RCC).With the latest supplemental new drug application (sNDA), which was accepted by the FDA in May this year, Pfizer is looking to get the label extended to include use in patients with high-risk of RCC recurrence.
The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for Sutent for the expanded indication. The FDA is expected to give a response in January 2018.
The sNDA in the United States was filed on the basis of aphase III study (S-TRAC) evaluating Sutent as an adjuvant treatment in patients at high risk of recurrent RCC, following nephrectomy (surgical removal of the cancer-containing kidney). Full data presented in October last year showed that Sutent extended disease-free survival (DFS) by more than a year compared to placebo, resulting in an overall risk reduction of 24%.
An application for use in the same patient population is also under review in the EU.
Sutent generated sales of $529 million in the first half of 2016, down 6% year over year due to competitive pressure in the United States and EU. If approved for the expanded patient population, sales of the drug might improve. It is estimated that 60% of high-risk patients will have RCC recurrence.
Pfizer’s shares have underperformed the industry this year so far. The stock has returned 9.1% during this period, comparing unfavorably with an increase of 16.4% for the industry.
Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stocks to Consider
Better-ranked large-cap drug stocks include Novartis (NVS - Free Report) , Novo Nordisk (NVO - Free Report) and Bayer (BAYRY - Free Report) , all with a Zacks Rank #2 (Buy).
Shares of Novartis are up 17.7% year to date. The Zacks Consensus Estimate for 2017 and 2018 climbed 0.4% and 1.2%, respectively, over the past 60 days.
Novo Nordisk’s shares up 35.7% this year so far. Its estimates have moved up 3.1% for 2017 while that for 2018 have increased 2.9% over the past 60 days.
Bayer’s stock is up 27.1% this year. Its estimates have moved up 4.1% for 2017 while that for 2018 have increased almost 1% over the past 60 days.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>