Pfizer seeks early approval for breast cancer drug

May 16, 2014 by The Associated Press

Pfizer Inc. says the Food and Drug Administration will let the drugmaker apply for approval of its heavily touted experimental breast cancer medicine based on midstage patient testing results.

That means New York-based Pfizer won't need bigger, very expensive, late-stage patient studies for palbociclib (pal-boh-SEYE'-klihb) to be approved.

The company says that after discussions with the FDA, the final results of a study called PALOMA-1 will be sufficient for review. The FDA last year designated palbociclib a breakthrough therapy, which speeds up the testing and approval process.

Pfizer says that by the third quarter, it will apply for approval to use palbociclib, together with a drug to prevent breast cancer recurrence called Femara, or letrozole, as an initial treatment for postmenopausal women with a certain type of advanced breast cancer.

Related Stories

Recommended for you

New treatment options for a fatal leukemia

July 27, 2015

In industrialized countries like in Europe, acute lymphoblastic leukemia is the most common form of cancer in children. An international research consortium lead by pediatric oncologists from the Universities of Zurich and ...

Modified DNA building blocks are cancer's Achilles heel

July 22, 2015

In studying how cells recycle the building blocks of DNA, Ludwig Cancer Research scientists have discovered a potential therapeutic strategy for cancer. They found that normal cells have highly selective mechanisms to ensure ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.