Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when the cancer treatment drug Sacituzumab Govitecan, also known as Trodelvy, will be available for prescription and use in the NHS.

Trodelvy (sacituzumab govitecan) does not yet have a marketing authorisation for use in Great Britain and is not yet available for routine prescribing. The Medicines and Healthcare products Regulatory Agency is currently considering a marketing authorisation application for Trodelvy through the accelerated process for Project Orbis medicines.

The National Institute for Health and Care Excellence (NICE) is also currently developing guidance for the National Health Service on whether Trodelvy represents a clinically and cost effective use of NHS resources. It expects to publish draft guidance in spring 2022. Interim access arrangements may be considered for medicines licensed through the Project Orbis pathway where NICE guidance is not anticipated to be published in line with the three month timeframe. NICE and NHS England and NHS Improvement are actively engaging with Gilead to see how interim access arrangements may be applied.