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.
You may also be interested in...
UK health technology assessment body NICE has struck deals with the makers of Enhertu for advanced breast cancer and Kesimpta for relapsing forms of multiple sclerosis.
Tuomo Pätsi of US biotech firm Seagen discusses plans for the rollout of Tukysa in Europe, how it successfully used a new mechanism for approval in Great Britain, and why the UK will be a go-to market for future innovative drug filings.
Companies seeking marketing authorizations in the UK or Great Britain will be able to make use of two new “reliance” procedures offering regulatory assessment times of 67 days or less if their products have already gone through the EU centralized or decentralized approval systems.