U.S. FDA Approval for Trodelvy® (sacituzumab govitecan-hziy) for HR+ HER2- metastatic patients. NHS approval is in progress.

At the beginning of February, Gilead Sciences announced that United States Food and Drug Administration (FDA) approval was obtained for Trodelvy® (sacituzumab govitecan-hziy). This is for HR+ HER2- metastatic patients who experience disease progression after hormone therapy and two or more systemic therapies (such as chemotherapies).

Unfortunately, HR+ HER2- metastatic patients can experience disease progression by becoming resistant to hormone therapy, which is included within the first line of treatment in this setting. These patients can then have limited treatment options and mainly will progress onto lines of chemotherapy.

A Phase III clinical trial (known as TROPiCS-02) showed that patients treated with sacituzumab govitecan-hziy, compared to patients treated with chemotherapy, lived longer and also had more time until further disease progression. You can read our previous in-depth blog post on the results of TROPiCS-02 here. 

The National Institute of Care Excellence (NICE), who determine if medications can be recommended for NHS usage in England and Wales, note that this usage of sacituzumab govitecan-hziy in the HR+ HER2- metastatic setting is currently under review. Review by the Scottish Medicines Consortium (SMC) for NHSScotland usage will therefore likely follow in due course. 

Sacituzumab govitecan-hziy is already approved by the NHS for UK wide usage of metastatic triple-negative breast cancer patients who have received two or more prior lines of systemic therapies.