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.
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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.
Advanced breast cancer treatment Enhertu and non-small cell lung cancer and thyroid cancer therapy Retsevmo are set to win conditional marketing authorizations in the EU shortly. The two drugs are among a number of new products that the European Medicines Agency has just recommended for approval.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.