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FDA Breakthrough Therapy Designation: Another For Targeted Lung Cancer

May 21, 2014

Clovis Oncology, a Colorado-based biopharmaceutical company focusing on developing and delivering cancer drugs through personalized medicine, announces May 19th that the FDA grants the Breakthrough Therapy Designation (BTD) to the company’s investigational agent CO-1686. The BTD is given to CO-1686 as monotherapy for the treatment of second-line EGFR mutant Non-Small Cell Lung Cancer (NSCLC), in patients with the T790M mutation. The BTD is based on interim efficacy and safety results from an ongoing Phase I/II study. Clovis Oncology plans on filing a New Drug Application (NDA) with the FDA by mid-2015.

Presentation of clinical data for CO-1686 is scheduled for Saturday, May 31st, at the American Society of Clinical Oncology’s (ASCO) Annual Meeting (Chicago), in a Clinical Science Symposium titled, “Targeting EGFR: The Next 10 Years”.

This is the 41st BTD announced by a sponsor company, the 1st BTD for Clovis Oncology, and the 5th BTD for targeted or personalized treatment of NSCLC :

Num Drug Name Sponsor Company Indication
1 LDK378 Novartis ALK+Non-SmallCell    LungCancer (NSCLC)
2 Alectinib Roche ALK+Non-SmallCell LungCancer(NSCLC)
3 Dabrafenib GlaxoSmithKline NSCLC with BRAF Mutation
4 AZD9291 AstraZeneca Metastatic EGFR T790M mutation-positive NSCLC
5 CO-1686 Clovis Oncology 2nd Line EGFR Mutant NSCLC with T790M Mutation




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: FDA Official Logo from FDA website.

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

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