Trodelvy

(asked on 15th October 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what representations he has made to the Medicines and Healthcare products Regulatory Agency on delays to the expected approval of Sacituzumab Govitecan, brand Trodelvy, for the treatment of metastatic breast cancer.


Answered by
Edward Argar Portrait
Edward Argar
Minister of State (Ministry of Justice)
This question was answered on 15th December 2021

We have made no such representations. Trodelvy (sacituzumab govitecan) was licensed for use by the Medicines and Health Care products Regulatory Agency (MHRA) in the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer through Project Orbis in August 2021. The National Institute for Health and Care Excellence (NICE) is appraising Trodelvy to determine its clinical and cost-effectiveness for use in the National Health Service. Following discussion with the manufacturer of Trodelvy, NICE has accelerated its appraisal and now expects to issue guidance in June 2022, with draft guidance expected in spring 2022.

The MHRA, NICE and NHS England and NHS Improvement are ensuring that there is a co-ordinated timely approach to supporting access for NHS patients to products licensed through Project Orbis. NHS England and NHS Improvement and NICE have agreed principles to allow potential interim access to medicines ahead of NICE guidance and are working with the manufacturer to explore options for interim access to Trodelvy.

Reticulating Splines