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Roche Alecensa Wins Second Breakthrough Status in the U.S.
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Roche Holding AG (RHHBY - Free Report) announced that its lung cancer drug, Alecensa, was granted a second breakthrough therapy designation in the U.S. for the treatment of advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in adult patients who have not received prior treatment with an ALK inhibitor.
This designation is granted by the FDA to expedite the development and review of drugs that are intended to treat serious diseases and provide access to patients as early as possible.
The designation was based on data from the phase III J-ALEX study, which demonstrated that Alecensa could reduce the risk of disease worsening or death by 66%, in comparison to Pfizer Inc.’s (PFE - Free Report) Xalkori (crizotinib), in patients with ALK-positive, advanced or recurrent NSCLC, who had either not been treated with chemotherapy or had received one prior line of chemotherapy.
We remind investors that in Jun 2013, the company had received the first breakthrough therapy designation for Alecensa for the treatment of patients with ALK-positive NSCLC whose disease progressed on treatment with Xalkori.
Currently, Alecensa is approved in the U.S. for the treatment of ALK-positive metastatic NSCLC patients who have progressed on or are intolerant to Xalkori.
Meanwhile, Alecensa is being evaluated in the phase III ALEX study, in comparison to Xalkori, as an initial (first-line) treatment for people with advanced ALK-positive NSCLC.
We note that the lung cancer treatment market is highly crowded with drugs like Opdivo, Keytruda and Zykadia among others.
As per information provided by the company, lung cancer causes 1.59 million deaths each year globally.
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs Herceptin, Perjeta and Kadcyla. The company's efforts to grow its portfolio beyond oncology and foray into new avenues such as multiple sclerosis and asthma are encouraging.
The company currently carries a Zacks Rank #3 (Hold).
Stocks to Consider
A couple of better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. , and VIVUS Inc. . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Achillion has posted a positive earnings surprise in each of the last four quarters, with an average beat of 364.79%. The company’s share price has tanked 22.3% year to date.
VIVUS has posted a positive earnings surprise thrice in the last four quarters, with an average beat of 39.88%. The company’s share price gained 7.5% year to date.
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Roche Alecensa Wins Second Breakthrough Status in the U.S.
Roche Holding AG (RHHBY - Free Report) announced that its lung cancer drug, Alecensa, was granted a second breakthrough therapy designation in the U.S. for the treatment of advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in adult patients who have not received prior treatment with an ALK inhibitor.
This designation is granted by the FDA to expedite the development and review of drugs that are intended to treat serious diseases and provide access to patients as early as possible.
ROCHE HLDG LTD Price
ROCHE HLDG LTD Price | ROCHE HLDG LTD Quote
The designation was based on data from the phase III J-ALEX study, which demonstrated that Alecensa could reduce the risk of disease worsening or death by 66%, in comparison to Pfizer Inc.’s (PFE - Free Report) Xalkori (crizotinib), in patients with ALK-positive, advanced or recurrent NSCLC, who had either not been treated with chemotherapy or had received one prior line of chemotherapy.
We remind investors that in Jun 2013, the company had received the first breakthrough therapy designation for Alecensa for the treatment of patients with ALK-positive NSCLC whose disease progressed on treatment with Xalkori.
Currently, Alecensa is approved in the U.S. for the treatment of ALK-positive metastatic NSCLC patients who have progressed on or are intolerant to Xalkori.
Meanwhile, Alecensa is being evaluated in the phase III ALEX study, in comparison to Xalkori, as an initial (first-line) treatment for people with advanced ALK-positive NSCLC.
We note that the lung cancer treatment market is highly crowded with drugs like Opdivo, Keytruda and Zykadia among others.
As per information provided by the company, lung cancer causes 1.59 million deaths each year globally.
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs Herceptin, Perjeta and Kadcyla. The company's efforts to grow its portfolio beyond oncology and foray into new avenues such as multiple sclerosis and asthma are encouraging.
The company currently carries a Zacks Rank #3 (Hold).
Stocks to Consider
A couple of better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. , and VIVUS Inc. . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Achillion has posted a positive earnings surprise in each of the last four quarters, with an average beat of 364.79%. The company’s share price has tanked 22.3% year to date.
VIVUS has posted a positive earnings surprise thrice in the last four quarters, with an average beat of 39.88%. The company’s share price gained 7.5% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>