Enhertu Nabs A First With UK Standalone Approval

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

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

More from Review Pathways

More from Pathways & Standards

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

House Gives US FDA More Non-User Fee Funds Than Requested

 

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.