Verdict expected for Pfizer's palbociclib in April

The FDA has granted a priority review to Pfizer's new drug application (NDA) for palbociclib as a first-line therapy in combination with letrozole as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease, the firm said on 13 October.

The FDA has granted a priority review to Pfizer's new drug application (NDA) for palbociclib as a first-line therapy in combination with letrozole as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease, the firm said on 13 October.

The agency is expected to make a decision by 13 April 2015, the experimental medicine's Prescription Drug User Fee Act...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Cardiovascular

Mineralys Eyes NDA As Lorundrostat Scores CKD Win In Race With AstraZeneca

 

As it races AstraZeneca’s baxdrostat to market, Mineralys plans to file an NDA later this year, backed by strong efficacy and safety data across four trials.

Merck & Co.’s Winrevair Positioned For Expansion On HYPERION Results

 

The Phase III trial met the primary endpoint of time to clinical worsening in patients newly diagnosed with pulmonary arterial hypertension.

Obesity Treatment Could Go Global With Lilly’s Orforglipron

 

The company’s oral GLP-1 candidate has reassured on its safety at the American Diabetes Association meeting, convincing analysts it will open up new global markets.

Lilly Agrees To Acquire PCSK9 Base-Editing Partner Verve

 
• By 

Instead of opting in on Phase II-ready PCSK9-targeted VERVE-102, Lilly will buy its partner for up to $1.3bn. Analysts call the deal a bargain for Lilly, but fair to Verve.

More from Therapy Areas

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By 

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.