HER2 Support Group Forums - View Single Post - GSK withdraws tykerb+herceptin application from FDA

Lani · 07-12-2012, 11:47 AM

GSK pulls U.S. bid to use Tykerb with Herceptin

LONDON | Thu Jul 12, 2012 11:03am EDT

(Reuters) - British group GlaxoSmithKline has pulled a U.S. application seeking approval to use its breast cancer drug Tykerb in combination with Roche's rival product Herception for certain patients with advanced disease.

A green light for combined administration of the two drugs would expand the use of GSK's Tykerb - sales of which have been limited - by offering a new treatment option for very sick women with metastatic cancer.

"Our discussions with FDA (U.S. Food and Drug Administration) highlighted questions that could not be addressed with the data currently available," said Rafael Amado, GSK's head of oncology R&D.

As a result, Britain's biggest drugmaker said it had decided to withdraw its application and wait for results from further ongoing studies testing the drug combination.

An FDA advisory committee had been scheduled to consider on July 24 the use of Tykerb with Herceptin for patients with metastatic breast cancer whose tumors over-express the HER2 protein and who have had prior Herceptin treatment.

Regulatory reviews of the drug combination are continuing in Europe and other countries despite the U.S. move.

(Reporting by Ben Hirschler; Editing by Dan Lalor)

07-12-2012, 11:47 AM	#1
Lani Senior Member Join Date: Mar 2006 Posts: 4,778	GSK withdraws tykerb+herceptin application from FDA GSK pulls U.S. bid to use Tykerb with Herceptin LONDON \| Thu Jul 12, 2012 11:03am EDT (Reuters) - British group GlaxoSmithKline has pulled a U.S. application seeking approval to use its breast cancer drug Tykerb in combination with Roche's rival product Herception for certain patients with advanced disease. A green light for combined administration of the two drugs would expand the use of GSK's Tykerb - sales of which have been limited - by offering a new treatment option for very sick women with metastatic cancer. "Our discussions with FDA (U.S. Food and Drug Administration) highlighted questions that could not be addressed with the data currently available," said Rafael Amado, GSK's head of oncology R&D. As a result, Britain's biggest drugmaker said it had decided to withdraw its application and wait for results from further ongoing studies testing the drug combination. An FDA advisory committee had been scheduled to consider on July 24 the use of Tykerb with Herceptin for patients with metastatic breast cancer whose tumors over-express the HER2 protein and who have had prior Herceptin treatment. Regulatory reviews of the drug combination are continuing in Europe and other countries despite the U.S. move. (Reporting by Ben Hirschler; Editing by Dan Lalor)