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ARIAD Finishes Rolling NDA for Lung Cancer Drug Brigatinib
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ARIAD Pharmaceuticals, Inc. announced the completion of the rolling submission of the new drug application (NDA) for its experimental ALK inhibitor, brigatinib, to the FDA. ARIAD is looking to get brigatinib approved for the treatment of patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) in patients who are resistant or intolerant to Pfizer Inc.'s (PFE - Free Report) Xalkori.
ARIAD is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application, which could shorten the review period from the standard 12 months to just 8 months.
We note that brigatinib enjoys Breakthrough Therapy status in the U.S. for the treatment of patients with ALK+ NSCLC whose tumors are resistant to Xalkori. Brigatinib also has Orphan Drug status in the U.S. for the treatment of ALK+ NSCLC.
The regulatory application included data from its phase I/II and pivotal phase II ALTA studies on brigatinib. With a median follow-up of 8.3 months, data demonstrated that 54% of patients, when treated with a 180-mg regimen with a seven-day lead-in at 90 mg, witnessed an investigator-assessed confirmed objective response – the primary endpoint of the study. In addition, median progression-free survival exceeded one year (12.9 months) in this arm.
ARIAD plans to submit a marketing authorization application for brigatinib to the European Medicines Agency in early 2017.
Meanwhile, the company has initiated a first-line phase III study (ALTA1L) comparing the efficacy and safety of brigatinib to Xalkori in patients with locally advanced or metastatic ALK+ NSCLC who have not previously been treated with an ALK inhibitor.
We are encouraged by the company’s progress with brigatinib. Currently, ARIAD has only one marketed product in its kitty — leukemia drug Iclusig. If brigatinib is finally approved, it could become a two-product commercial company by early 2017.
ARIAD is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Geron Corporation (GERN - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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ARIAD Finishes Rolling NDA for Lung Cancer Drug Brigatinib
ARIAD Pharmaceuticals, Inc. announced the completion of the rolling submission of the new drug application (NDA) for its experimental ALK inhibitor, brigatinib, to the FDA. ARIAD is looking to get brigatinib approved for the treatment of patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) in patients who are resistant or intolerant to Pfizer Inc.'s (PFE - Free Report) Xalkori.
ARIAD is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application, which could shorten the review period from the standard 12 months to just 8 months.
We note that brigatinib enjoys Breakthrough Therapy status in the U.S. for the treatment of patients with ALK+ NSCLC whose tumors are resistant to Xalkori. Brigatinib also has Orphan Drug status in the U.S. for the treatment of ALK+ NSCLC.
The regulatory application included data from its phase I/II and pivotal phase II ALTA studies on brigatinib. With a median follow-up of 8.3 months, data demonstrated that 54% of patients, when treated with a 180-mg regimen with a seven-day lead-in at 90 mg, witnessed an investigator-assessed confirmed objective response – the primary endpoint of the study. In addition, median progression-free survival exceeded one year (12.9 months) in this arm.
ARIAD plans to submit a marketing authorization application for brigatinib to the European Medicines Agency in early 2017.
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Meanwhile, the company has initiated a first-line phase III study (ALTA1L) comparing the efficacy and safety of brigatinib to Xalkori in patients with locally advanced or metastatic ALK+ NSCLC who have not previously been treated with an ALK inhibitor.
We are encouraged by the company’s progress with brigatinib. Currently, ARIAD has only one marketed product in its kitty — leukemia drug Iclusig. If brigatinib is finally approved, it could become a two-product commercial company by early 2017.
ARIAD is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Geron Corporation (GERN - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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>>