The statement below is an extract from the FDA.gov website reporting on this approval. What I find a bit disappointing is that the FDA mentions that this drug may affect cardiac electrical properties. It was our hope that the relugolix would be less cardiotoxic than Lupron, because the only other direct LHRH antagonist, Firmagon (degarelix) is believed to be less cardiotoxic than all the other LHRH direct agonists (Lupron, Eligard, Zoladex, etc.). It could be that FDA is just being cautious and waiting for more data to see if, indeed, relugolix is less cardiotoxic than the direct LHRH agonists. Time will tell.
From the FDA:
Today, the U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.
“Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”
The most common side effects of Orgovyx include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes. Androgen deprivation therapies such as Orgovyx may affect the heart’s electrical properties or cause electrolyte abnormalities, therefore healthcare providers should consider periodic monitoring of electrocardiograms and electrolytes.
For the complete FDA press release, click here: http://tiny.cc/FDA-relugolix
For the complete FDA prescribing info (18 technical pages) click here: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214621s000lbl.pdf