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Early EU Approval Wins In Line For Daiichi/AZ & Lilly

Another Cancer Drug - Lumoxiti - Is Also On Track For Special Approval

Executive Summary

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.

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Enhertu Nabs A First With UK Standalone Approval

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.

Plenty Of Action On EU Accelerated Assessment Front

A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.

European CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

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