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Roche's Perjeta Gets FDA Nod for Post Surgery Breast Cancer
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Roche Holding AG’s (RHHBY - Free Report) announced that the FDA has approved Perjeta (pertuzumab), in combination with Herceptin and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. Patients should receive the adjuvant Perjeta-based regimen for one year (18 cycles).
Perjeta in combination with Herceptin and docetaxel is already approved for use in patients who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
Coming back to the release, the approval for the indication was based on results of the phase III APHINITY study. The study showed that Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 18% compared to Herceptin and chemotherapy alone. The combination wasalso granted a Priority Review by the FDA in October.
While, invasive disease-free survival (DFS),served as the primary endpoint, secondary endpoints included overall and cardiac safety, DFS and health-related quality of life.
In addition, the FDA granted full approval to use of that same regimen for neoadjuvant treatment of HER-2-positive, locally advanced, inflammatory or early-stage breast cancer. Until now, the neoadjuvant indication had been allowed under accelerated approval. Roche’s stock has rallied 8% year to date compared with industry’s gain of 16.1%.
The company has a strong presence in the oncology market. It dominates the breast cancer space with strong demand for its HER2 franchise drugs like Herceptin, Perjeta and Kadcyla. Herceptin’s growth is g driven by improved demand in both the United States and Europe due to longer treatment duration. Moreover, the subcutaneous formulation of Herceptin is being increasingly adopted across Europe. Meanwhile, sales of Perjeta have been strong in Europe largely due to uptake in the neo-adjuvant setting and persistent growth in the metastatic setting. Kadcyla sales are being driven by increasing demand in both the Europe and internationally. Apart from its strong breast cancer franchise, Roche’s oncology portfolio also boasts drugs like Avastin and Tarceva for lung cancer.
However, we note that Roche is facing stiff competition from the likes of Merck & Co., Inc.’s (MRK - Free Report) Keytruda and Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in the immuno-oncology space.
Sucampo’s earnings per share estimates have moved up from 31 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 23.2% year to date.
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Roche's Perjeta Gets FDA Nod for Post Surgery Breast Cancer
Roche Holding AG’s (RHHBY - Free Report) announced that the FDA has approved Perjeta (pertuzumab), in combination with Herceptin and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. Patients should receive the adjuvant Perjeta-based regimen for one year (18 cycles).
Perjeta in combination with Herceptin and docetaxel is already approved for use in patients who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
Coming back to the release, the approval for the indication was based on results of the phase III APHINITY study. The study showed that Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death by 18% compared to Herceptin and chemotherapy alone. The combination wasalso granted a Priority Review by the FDA in October.
While, invasive disease-free survival (DFS),served as the primary endpoint, secondary endpoints included overall and cardiac safety, DFS and health-related quality of life.
In addition, the FDA granted full approval to use of that same regimen for neoadjuvant treatment of HER-2-positive, locally advanced, inflammatory or early-stage breast cancer. Until now, the neoadjuvant indication had been allowed under accelerated approval. Roche’s stock has rallied 8% year to date compared with industry’s gain of 16.1%.
The company has a strong presence in the oncology market. It dominates the breast cancer space with strong demand for its HER2 franchise drugs like Herceptin, Perjeta and Kadcyla. Herceptin’s growth is g driven by improved demand in both the United States and Europe due to longer treatment duration. Moreover, the subcutaneous formulation of Herceptin is being increasingly adopted across Europe. Meanwhile, sales of Perjeta have been strong in Europe largely due to uptake in the neo-adjuvant setting and persistent growth in the metastatic setting. Kadcyla sales are being driven by increasing demand in both the Europe and internationally. Apart from its strong breast cancer franchise, Roche’s oncology portfolio also boasts drugs like Avastin and Tarceva for lung cancer.
However, we note that Roche is facing stiff competition from the likes of Merck & Co., Inc.’s (MRK - Free Report) Keytruda and Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in the immuno-oncology space.
Roche Holding AG Price
Roche Holding AG Price | Roche Holding AG Quote
Zacks Rank & Stock to Consider
Roche carries a Zacks Rank #4 (Sell).
A better-ranked stock in the same space is Sucampo Pharmaceuticals carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have moved up from 31 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%. The share price of the company has increased 23.2% year to date.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can 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.
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