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FDA Breakthrough Therapy Designation: ARIAD Pharmaceuticals And ALK+ Non-Small Cell Lung Cancer

October 2, 2014

On October 2nd, ARIAD Pharmaceuticals announces that the company’s investigational oral cancer medicine, AP26113, receives the coveted FDA Breakthrough Therapy Designation (BTD). The BTD is for Anaplastic Lymphoma Kinase positive (ALK+) metastatic Non-Small Cell Lung Cancer (NSCLC), for patients who are resistant to Pfizer’s orphan drug Xalkori (Crizotinib).

The BTD is based on an ongoing Phase I/II trial that shows sustained anti-tumor activity of AP26113 for ALK+ NSCLC. Of the 72 ALK+ NSCLC patients evaluable for response in this clinical trial:

•   72% of the patients demonstrated an objective response

•   Median duration of response was 49 weeks

•   Median Progression-Free Survival (PFS) was 56 weeks.

In March 2014 , ARIAD Pharmaceuticals announces the start of the global pivotal Phase II ALTA Trial of AP26113 in patients with locally advanced or metastatic NSCLC who test positive for the ALK oncogene and were treated with Xalkori previously.

According to the American Cancer Society, the most common form of lung cancer is NSCLC – about 85% of an estimated 228,190 new cases of lung cancer diagnosed each year in the US. 3 – 8% of NSCLC patients have the ALK gene mutation.

3 FDA BTDs For ALK+ NSCLC Indication

# Drug Name Sponsor Company Indication
1 LDK378 Novartis ALK+Non-SmallCell    Lung

Cancer (NSCLC)

2 Alectinib Roche ALK+Non-SmallCell Lung



3 AP26113 Ariad Pharmaceuticals ALK+ Non-Small Cell Lung Cancer (NSCLC) Resistant to Crizotinib



ARIAD Pharmaceuticals Pipeline


FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “IMG Carlingford Lough 0617” by Sarah777 at en.wikipedia [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

  1. Anonymous permalink

    In the latest FDA report the CBER BTD granted went up by one in the month of September. I am assuming the 3 listed above are all CDER. Do we know who was issued the CBER BTD last month? Thanks.

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