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AstraZeneca, Daiichi Sankyo's Enhertu Gets Conditional UK Approval in Metastatic Breast Cancer

NEW YORK – AstraZeneca and Daiichi Sankyo said on Tuesday that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorization to their antibody drug conjugate trastuzumab deruxtecan (Enhertu) as a monotherapy for previously-treated, metastatic, HER2-positive breast cancer patients.

The MHRA's conditional authorization for trastuzumab deruxtecan in the UK follows roughly a month after the European Medicines Agency (EMA) issued the same decision for the agent in the European Union. Both agencies conditionally approved trastuzumab deruxtecan based on data from the Phase II DESTINY-Breast01 trial, in which there was a 61 percent objective response rate among patients receiving the drug. Complete responses were observed in 6.5 percent of patients, and the median duration of response was 20.8 months. The agent has also received regulatory approval for this same indication in the US and Japan.

Conditional authorization in the EU and UK is reserved for treatments that fill an unmet need, and for which the benefit clearly outweighs the risk. Further data collection is required to support the agent's permanent approval. Daiichi Sankyo and AstraZeneca are currently evaluating the agent in multiple randomized Phase III trials.

Following the MHRA's conditional authorization, the UK's National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium will appraise the agent's clinical and cost effectiveness and decide whether the National Health Service should fund the drug for breast cancer patients. An access decision is anticipated by the end of 2021.

"This authorization by the MHRA and EMA is the first for a medicine using our proprietary Dxd antibody drug conjugate technology and highlights the strength of the Daiichi Sankyo and AstraZeneca collaboration," Haran Maheson, Daiichi Sankyo UK's commercial director for oncology, said in a statement. "We will now work closely in partnership with the MHRA to fulfill all regulatory requirements before stock can be available in the UK."