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  • FDA Approves first...

FDA Approves first Oral Hormone Therapy for Treating Advanced Prostate Cancer

Written By : Hina Zahid |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2020-12-20T20:43:21+05:30  |  Updated On 21 Dec 2020 3:40 PM IST
FDA Approves first Oral Hormone Therapy for Treating Advanced Prostate Cancer
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The FDA has approved relugolix an oral androgen deprivation therapy ADT for men with advanced prostate cancer. The FDA granted approval of Orgovyx to Myovant Sciences.

"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 American Cancer Society estimates that in 2020, there will have been more than 190,000 cases of prostate cancer in the U.S. One of the treatment options for advanced prostate cancer is androgen deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow. Current FDA-approved treatments of this type are injected or placed as small implants under the skin. Orgovyx is an orally administered treatment that works by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make.

The safety and efficacy of Orgovyx was evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The objective was to determine if Orgovyx achieved and maintained low enough levels of testosterone (castrate levels), by day 29 through end of the treatment course. In the 622 patients who received Orgovyx, the castration rate was 96.7%.

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. Based on findings in animals and the mechanism of action, Orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female; it is advised that males with female partners of reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx. Due to the drug's suppression of the pituitary gonadal system, diagnostic test results of the pituitary gonadotropic and gonadal functions conducted during and after taking Orgovyx may be affected.

fdafood and drug administrationoral hormone therapyprostate cancerorgovyxrelugolixandrogen deprivation therapy
Source : FDA
Hina Zahid
Hina Zahid

    Hina Zahid Joined Medical Dialogue in 2017 with a passion to work as a Reporter. She coordinates with various national and international journals and association and covers all the stories related to Medical guidelines, Medical Journals, rare medical surgeries as well as all the updates in the medical field. Email: editorial@medicaldialogues.in. Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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