1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Review Pathways

Enhertu Nabs A First With UK Standalone Approval

Advanced Breast Cancer Treatment Is First New Cancer Drug Approved In 2021

 
• By Vibha Sharma

The UK conditional approval of Daiichi Sankyo/AstraZeneca’s advanced breast cancer drug Enhertu was issued in accordance with “transitional provisions” that apply to drugs that received a positive opinion from the European Medicines Agency before the end of the Brexit transition period.

Realistic pink ribbon, breast cancer awareness symbol, vector illustration
There is significant unmet clinical need for patients with HER2 positive metastatic breast cancer • Source: Shutterstock

Daiichi Sankyo/AstraZeneca’s Enhertu (trastuzumab deruxtecan) has become the first new cancer medicine to be authorized by the UK’s Medicines and Healthcare products Regulatory Agency since it became an independent regulator in January following the end of the Brexit transition period.

Enhertu has been granted conditional authorization in the UK as a monotherapy for the treatment of adult patients with unresectable...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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
Start Free Trial

Already a subscriber?

More from Review Pathways

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 
• By Neena Brizmohun

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
• By Derrick Gingery

The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

More from Pathways & Standards

US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
• By Derrick Gingery

The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.