US FDA orders ESA labelling changes to narrow use

The US FDAhas ordered labelling changes for erythropoiesis-stimulating agents (ESAs) to advise against use in patients receiving chemotherapy in the adjuvant setting and place a haemoglobin level ceiling for initiation of treatment. However, the FDA opted not to restrict use of the anaemia treatments in patients according to tumour types, despite a recommendation to the contrary by its oncologic drugs advisory panel.

The US FDAhas ordered labelling changes for erythropoiesis-stimulating agents (ESAs) to advise against use in patients receiving chemotherapy in the adjuvant setting and place a haemoglobin level ceiling for initiation of treatment. However, the FDA opted not to restrict use of the anaemia treatments in patients according to tumour types, despite a recommendation to the contrary by its oncologic drugs advisory panel.

Although the decision not to restrict use based on tumour type is a huge win for Amgen, the company is...

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 Therapeutic Category

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By 

Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.