FDA Grants Fast Track Designation For Boehringer Ingelheim's BIBW 2992 For The Treatment Of Late Stage Non Small Cell Lung Cancer (NSCLC)

Main Category: Lung Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 15 Feb 2008 - 2:00 PDT

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Boehringer Ingelheim's investigational cancer treatment BIBW 2992 has recently received a Fast Track Designation status by the FDA. Under this designation, Boehringer Ingelheim will conduct a pivotal trial programme studying BIBW 2992 in a non-small cell lung cancer (NSCLC) patient group where prior treatment with reversible EGFR inhibitors has failed.

The FDA`s Fast Track Programme will facilitate the development programme and expedite the review of new treatments that demonstrate the potential to address an unmet medical need in serious or life-threatening diseases.

"We are pleased that the FDA acknowledges the therapeutic potential of BIBW 2992 by granting a Fast Track Designation." stated Dr Andreas Barner, Member of the Board of Managing Directors of Boehringer Ingelheim and responsible for Research, Development and Medicine. "We are confident that the pharmacologic evidence of activity in this indication and data from the clinical development programme will support the use of BIBW 2992 for patients who have hardly any treatment option left".

If approved Boehringer Ingelheim will market the compound under the trade name TOVOK™.

About the FDA Fast Track Designation

Fast Track is a formal mechanism to interact with the FDA using approaches that are available to all applicants for marketing claims. The Fast Track mechanism is described in the Food and Drug Administration Modernization Act of 1997 (FDAMA). The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 47 countries and more than 38,000 employees. Since it was founded in 1885, the privately-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.5 billion euro while spending nearly one fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

Boehringer Ingelheim
http://www.boehringer-ingelheim.com

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