LAUSR

We reviewed the available animal and human reproductive function studies of recently-approved non-cytotoxic oncology drugs. We reviewed the oncofertility information in the prescribing information for Food and Drug Administration (FDA)-approved products and/or the product information and consumer medicine information for Therapeutic Goods Administration (TGA)-approved drugs of 32 novel oncology drugs approved between 2014-2018 in the USA and/or Australia supplemented by a literature review for additional reproductive effects. No human studies were available on the reproductive effects of all 32 drugs. A systematic literature review of animal reproductive toxicity studies provided only very limited data with 9 drugs displaying impaired male fertility, 3 impaired female fertility and 9 producing impaired fertility in both males and females. Two drugs in the study are reported to have no demonstrable impact on fertility in animal reproductive toxicity studies and 9 are reported to have unknown effects on fertility. Of the 32 newly listed drugs, only 4 had recommendations regarding potential human fertility risks and accordingly advised clinicians about fertility preservation procedures for patients. The lack of human data and limited animal reproductive toxicity data raises concerns about potential impact of these novel oncology drugs on human fertility and reproductive function. Consequently, adequate oncofertility recommendations including for fertility preservation procedures, counselling for psychological or cost implications and future prognosis for fertility are hindered by this paucity of relevant data. More data on human reproductive effects of novel oncology drugs is urgently required to facilitate effective use of the growing array of oncofertility care options available.