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Clinical Study
In September 2011 ARIAD Pharmaceuticals, Inc. initiated Phase 1/2 clinical trial of brigatinib (AP26113) conducted in patients with advanced malignancies, including anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC). Beginning in March 2014, the global Phase 2 ALTA study was conducted in patients with locally advanced or metastatic NSCLC who test positive for the ALK oncogene and were previously treated with crizotinib. This registration study enrolled approximately 220 patients at approximately 75 sites in North America, Europe and Asia. The primary endpoint of the Phase 2 trial is objective response rate as measured by RECIST criteria. Brigatinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2014. In March 2016, The Phase 3 Multicenter Open-label Study of brigatinib was initiated in adult patients with ALK-positive locally advanced or metastatic NSCLC who have not previously been treated with an ALK inhibitor, which is designed to assess the efficacy of brigatinib in comparison to crizotinib based on evaluation of the primary endpoint of progression free survival. Research data from Phase 3 trial suggested that in the ALK TKI-naive group, it could potentially change patients’ natural history by better suppressing ALK+ disease from the beginning. On 15 April 2016, ARIAD reported their updated results from the Phase ½ trial, a one year overall survival rate of 100 percent in crizotinib-naive patients, and 81 percent in patients with prior crizotinib treatment, as well as predictable pharmacokinetic data. .  An Expanded Access Study was further evaluated in May 2016.

Regulatory Approval
Ariad Pharmaceuticals, Inc. filed an investigational new drug (IND) application to the US FDA on August 29, 2016.

In 2016, brigatinib was granted orphan drug status by the FDA for treatment of NSCLC.

In 28 April 2017, it was granted an Accelerated Approval from the US FDA for metastatic non-small cell lung cancer (NSCLC); as a 2nd-line therapy for ALK-positive NSCLC.

Intellectual Property
On 22 April 2015 ARIAD Pharmaceuticals, Inc. announced the issuance of its first U.S. patent on brigatinib, the protection is through December 30, 2030. The United States Patent and Trademark Office granted U.S. Patent No. 9,012,462 under the title, “Phosphorous Derivatives as Kinase Inhibitors.”

Commercialization
Alunbrig (brigatinib) is manufactured by ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) which is focused on rare cancers. ARIAD then was acquired by Takeda Pharmaceutical Company Limited (TSE: 4502) in February 2017 through a tender offer (for $24.00 per share in cash) and subsequent merger of ARIAD with Kiku Merger Co., Inc., a wholly owned subsidiary of Takeda Pharmaceuticals U.S.A. ARIAD is now an indirect wholly owned subsidiary of Takeda.