Pfizer Breast Cancer Drug Gets FDA's 'Breakthrough' Status

Law360, New York (April 10, 2013, 6:37 PM EDT) -- Pfizer Inc. announced Wednesday that its experimental breast cancer treatment palbociclib had been granted “breakthrough therapy” status by the U.S. Food and Drug Administration under a recently implemented program for promising drugs, opening the door for expedited regulatory approval.

Although the FDA hadn’t yet set out its requirements for any expedited regulatory approval submission for palbociclib, Pfizer will work with the agency to understand the breakthrough therapy program and generate the necessary evidence to support any potential submission, the company said.

“We appreciate the opportunity that...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.