FOI release
Fezolinetant SmPC & breast cancer
Some or all of the information requested may not have been provided because we required clarification from the requester.
Case reference FOI2026/01059
Received 15 September 2026
Published 28 October 2026
Request
I would like to be sent all the information submitted by Astellas to support the licensing and wording of the SmPC for Fezolinetant In regards to breast cancer as per wording in section 4.4 (as below), as well as the documentation in relation to the MHRA in how it came to agree this wording. The SmPC contains the wording below in Regards to breast cancer 4.4 Special warnings and precautions for use Known or previous breast cancer or oestrogen-dependent malignancies Women undergoing oncologic treatment (e.g., chemotherapy, radiation therapy, antihormone therapy) for breast cancer or other oestrogen-dependent malignancies have not been included in the clinical studies. Therefore, Veoza is not recommended for use in this population as the safety and efficacy are unknown. Women with previous breast cancer or other oestrogen-dependent malignancies and no longer on any oncologic treatment have not been included in the clinical studies. A decision to treat these women with Veoza should be based on a benefit-risk consideration for the individual. The SmPC contains no data to support the above and SKYLIGHY-1 and SKYLIGHT-2 excluded people with a history of breast cancer, and this is clearly stated in the wording above for both groups. I therefore wish to understand what information was submitted to the MHRA by Astellas in regards to this and how the MHRA came to make this decision in relation to the wording related to breast cancer given the referenced data in the SmPC.
Response
See attached
Documents
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