Links

• American Heart Association (AHA) scientific statement on the impact of hormonal therapies for treatment of hormone-dependent cancers on the cardiovascular system

  This consensus statement highlights the increase in cardiovascular morbidity and mortality experienced by survivors of prostate (and breast) cancer as a result of the hormone therapies (eg GnRH analogues) that serve as a backbone for treatment and provides an evidence-based approach to prevent and detect adverse cardiovascular outcomes. It states that androgen deprivation therapy for prostate cancer appears to increase the risk of cardiovascular events, although GnRH antagonists are associated with a lower risk of cardiovascular events than GnRH agonists.

  https://www.ahajournals.org/doi/10.1161/HCG.0000000000000082
• Food and Drug Administration (FDA) guidance to develop a GnRH analogue for advance prostate cancer

  This guidance for industry describes the (FDA’s) current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer. It clearly outlines the FDA’s expectations for the pivotal, registration study design and data expected to be submitted in a New Drug Application (NDA) in order for a new GnRH analogue to obtain approval.

  https://www.fda.gov/media/129027/download