🩺 FDA eases hormone therapy cancer warnings after review

The FDA will remove boxed warnings for breast cancer and cardiovascular risk from menopausal hormone therapies (MHTs) after re-evaluating evidenceincluding new analyses of WHI dataaltering decades-old guidance for VMS treatments.

Why It Matters To Oncology

▪ WHI's original findings chilled hormone therapy use and menopause research due to cancer concerns.

▪ FDA now cites newer data: MHTs are not linked to increased cancer mortality and may lower all-cause mortality and fracture risk.

▪ The move could shift clinical practice and revive interest in MHTs for symptom control in postmenopausal women.

The Financials

▪ Bayer recently launched Lynkuet (elinzanetant), a non-hormonal VMS therapy, following Astellas' Veozah (fezolinetant).

▪ Label changes could expand the MHT market but also intensify competition with non-hormonal options.

▪ Drugmakers may see renewed commercial opportunities in both traditional and novel menopause therapies.

What They're Saying

▪ Yesmean Wahdan (Bayer) notes menopause "is now at centre stage" for research and drug development.

▪ FDA and HHS highlight WHI's age/methodology limits; newer data support lower risk in typical MHT populations.

▪ Physician surveys show enthusiasm for new options but cautious about side effectse.g., CNS effects for Lynkuet, liver monitoring for Veozah.

What's Next

▪ FDA will work with manufacturers to update MHT labels, keeping endometrial cancer warnings for oestrogen-alone products.

▪ Expect increased research, more nuanced patient discussions, and potential spike in demand for both MHT and non-hormonal alternatives.