US-based pharmaceutical company Pfizer has submitted a new drug application (NDA) for palbociclib to the US Food and Drug Administration (FDA).

Palbociclib is an investigational oral targeted agent, which selectively inhibits cyclin-dependent kinases (CDKs) four and six to regain cell cycle control and block tumour cell proliferation.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The company is seeking approval for palbociclib, in combination with letrozole, to treat post-menopausal women with estrogen receptor positive (ER+) and human epidermal growth factor receptor two negative (HER2-) advanced breast cancer.

"Today’s submission marks an important milestone for Pfizer and palbociclib."

Pfizer Oncology president Garry Nicholson said: "Today’s submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer."

Pfizer has submitted the application based on the final results of PALOMA-1, a randomised, phase II trial comparing palbociclib plus letrozole with just letrozole.

See Also:

PALOMA-1 was designed to assess progression-free survival in post-menopausal women with ER+, HER2- advanced breast cancer who were receiving palbociclib in combination with letrozole rather than just letrozole.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company has presented the PALOMA-1 final results at the American Association for Cancer Research (AACR) Annual Meeting 2014.

In addition, the company has started two phase III studies of palbociclib in advanced / metastatic breast cancer.

In April 2013, Palbociclib received Breakthrough Therapy designation from the FDA to treat women with advanced or metastatic ER+, HER2- breast cancer.

Pfizer noted that palbociclib is not approved for any indication in any market.