FDA grants fast track designation for Boehringer Ingelheim's BIBW 2992

Boehringer IngelheimBoehringer 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.

About 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. For further information, visit www.boehringer-ingelheim.com.

Most Popular Now

Amgen and Allergan's MVASI™ (bevacizumab-awwb) and…

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTITM (trastuzumab-anns), a bio...

Compound found in red wine opens door for new trea…

Like to unwind with a glass of red wine after a stressful day? Don't give alcohol all the credit. New research has revealed that the plant compound resveratrol, which is ...

Mylan and Upjohn, a division of Pfizer, to combine…

HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. (Nasdaq: MYL) and Pfizer Inc. (NYSE: PFE) today announced a definitive agreement to combine Mylan with Upjohn, Pfizer's o...

HIV vaccine nears clinical trial following new fin…

A promising vaccine that clears an HIV-like virus from monkeys is closer to human testing after a new, weakened version of the vaccine has been shown to provide similar p...

Closing the door: breaking new ground related to a…

In order to sustain fast growth, cancer cells need to take up nutrients at a faster rate than healthy cells. The human glutamine transporter ASCT2 allows the amino acid g...

Leading oncologists and nutritionists pinpoint are…

An international collaborative led by Ludwig Cancer Research and Cancer Research UK has identified key areas that are central to uncovering the complex relationship betwe...

Roche and Spark Therapeutics, Inc. announce extens…

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) ("Spark") announced that Roche has extended the offering period of its previously announced...

Rye is healthy, thanks to an interplay of microbes

Eating rye comes with a variety of health benefits. A new study from the University of Eastern Finland now shows that both lactic acid bacteria and gut bacteria contribut...

Eating more plant-based foods may be linked to bet…

Eating mostly plant-based foods and fewer animal-based foods may be linked to better heart health and a lower risk of dying from a heart attack, stroke or other cardiovas...

FDA approves first treatment for severe hypoglycem…

The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that c...

GSK completes transaction with Pfizer to form new …

The Joint Venture brings together two highly complementary portfolios of trusted consumer health brands, including GSK's Sensodyne, Voltaren and Panadol and Pfizer's Advi...

Bayer acquires BlueRock Therapeutics to build lead…

Bayer AG and BlueRock Therapeutics today announced an agreement under which Bayer will fully acquire BlueRock Therapeutics, a privately held US-headquartered biotechnolog...