Pfizer breast cancer drug to get FDA priority review

October 13, 2014

Pfizer said Monday an experimental breast cancer treatment will be given an accelerated review by US regulators, speeding up the process for potential approval.

The US Food and Drug Administration has granted priority review for palbociclib, which would treat certain postmenopausal women with advanced , the US pharmaceutical giant said.

Under the priority review status, the FDA accelerates the review time from 10 months to a goal of six months, with a decision on approval expected by April 13, 2015, it said.

In April, Pfizer said a clinical trial had shown palbociclib slows the growth of advanced cancer.

Administered with another drug already on the market, letrozole, an aromatase inhibitor, the treatment stops cancer growth for 20 months on average, it said.

The experimental treatment is aimed at postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) who have not received previous systemic treatment for their advanced disease.

"If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the US who are living with ," said Garry Nicholson, president of Pfizer Oncology, in a statement.

Pfizer, which lost its global number-one status to Swiss rival Novartis, is searching for new drugs to renew growth. In recent years, patents have expired on most of its blockbusters—drugs that have a billion dollars in annual sales—and the company is facing stiff competition from generic versions.

Shares in Dow member Pfizer were down 0.1 percent at $29.10 in midday trade in New York.

Explore further: Pfizer seeks early approval for breast cancer drug

Related Stories

Pfizer seeks early approval for breast cancer drug

May 16, 2014
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.

Pfizer breast cancer drug gets breakthrough label

April 10, 2013
Pfizer Inc. says its experimental pill for advanced, often deadly breast cancer has been designated as a breakthrough therapy by the Food and Drug Administration.

Pfizer breast cancer drug hits midstage study goal (Update)

February 3, 2014
Drugmaker Pfizer Inc. said Monday that a midstage study of its experimental drug for advanced breast cancer, palbociclib, met the main goal.

Pfizer reports promising results for cancer drug

April 7, 2014
An experimental drug has shown encouraging results in treating advanced breast cancer in an early clinical trial, pharmaceutical giant Pfizer reported Sunday.

Palbociclib shows promising results in patients with hormone receptor-positive metastatic breast cancer

April 7, 2014
The drug palbociclib, an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, significantly improved progression-free survival when administered as a first-line treatment in patients with hormone receptor-positive, metastatic ...

Roche breast cancer drug 'helps patients live longer': study

September 29, 2014
A drug developed by Swiss giant Roche to treat an aggressive form of breast cancer has been shown to extend patients' lives by almost 16 months, researchers said Sunday.

Recommended for you

New wave of complex street drugs puzzles emergency doctors

August 21, 2018
At a time when drug overdoses are becoming more prevalent and lethal, a new report provides a snapshot of regional illicit drug use and, for the first time, highlights the complexity of detecting and treating patients at ...

Study finds racial disparities in prescribing opioids for chronic pain

August 20, 2018
Yale researchers have identified racial disparities in the treatment of patients who are prescribed opioids for chronic pain. Black patients who receive opioids long-term are more likely than whites to be tested for illicit ...

Proposal seeks to improve assessment of drug risks

August 20, 2018
A drug policy researcher is proposing a suite of changes to overhaul the Multi-Criteria Drug Harm Scale (MCDHS), which informs drug policies across Europe. The changes focus on addressing use and abuse separately, collecting ...

US approves first generic competitor to Mylan's EpiPen

August 16, 2018
US regulators Thursday approved the first generic alternative for the EpiPen, a life-saving emergency allergy medicine, two years after soaring prices for the original version owned by Mylan stoked controversy.

Study: What patients really think about opioid vs non-opioid medications for chronic pain

August 14, 2018
Prescriptions of opioids for chronic pain has increased dramatically since the 1990s in spite of their known harms. Despite a shortage of scientific studies on the long-term effectiveness of opioids such as morphine, oxycodone ...

Doctors nudged by overdose letter prescribe fewer opioids

August 9, 2018
In a novel experiment, doctors got a letter from the medical examiner's office telling them of their patient's fatal overdose. The response: They started prescribing fewer opioids.

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.