Prostate Cancer Drug Can Treat Uterine Fibroids
In 71 percent of women with uterine fibroids, daily relugolix therapy can reduce menstrual bleeding by at least half without affecting bone density.
These results obtained from the LIBERTY 2 trial, are published in The New England Journal of Medicine.
The U.S. Food and Drug Administration has approved relugolix from Myovant Sciences in the year 2020 for the treatment of advanced prostate cancer. It is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist that is being reviewed by the FDA as a uterine fibroid therapy.
‘Uterine fibroids can be treated by prostate cancer drug- relugolix. Daily administration of relugolix reduces menstrual bleeding by at least half without affecting bone density. Post US FDA approval, this drug can be a viable and non-surgical option to treat uterine fibroids.’
Uterine fibroids are non-cancerous growths in the uterus that develop during women's childbearing years. In the LIBERTY 1 trial that involved 388 women, 73 percent of the participants who received relugolix had a reduction in menstrual blood loss of at least 50 percent and a volume of less than 80 ml.
Chief author Dr. Ayman Al-Hendy told Reuters Health that, "For the first time we have a good, reliable, long-term treatment for fibroids as an alternative to surgery. I'm hoping this will make a dent in the number of hysterectomies."
Myovant analyzed the data in which most women received the drug relugolix in combination with 1 mg of estradiol and 0.5 mg of norethindrone acetate to counter the side effects of relugolix alone.
Al-Hendy and his team reported that a full year of treatment reduced mean menstrual blood volume by nearly 90 percent, with amenorrhea (absence of menstrual cycle) seen in more than two thirds of the women.
Till the age of 50, an estimated 70% of white women and 80% of Black women have at least one fibroid. One fourth of the patients experience heavy menstrual bleeding and sometimes pain.
Dr. Al-Hendy said that contraceptive therapy provides temporary relief but majority of patients do not respond after three to six months. The reliable alternative is surgery.
Based on data following volunteers for up to two years, this new treatment can get FDA approval sometime during summer. This will be viable, non-surgical alternative for the treatment of fibroids.
The LIBERTY studies were conducted in women between the ages of 18 to 50 for duration of 24 weeks. In this study, one third received placebo while another third received relugolix combination therapy while the remaining received relugolix alone for 12 weeks followed by the relugolix combination for another 12 weeks.
The women were assessed every 4 weeks and blood loss was measured during the final month of treatment.
In 71 percent of the relugolix participants, menstrual blood loss was cut by at least half compared to 15 percent of placebo patients.
Source: Medindia