First one-day advanced prostate cancer drug approved by FDA!

On December 18th Myovant Sciences, a healthcare company focused on redefining male and female sexual care, announced that the FDA had approved ORGOVYX™ for the treatment of adult patients with advanced prostate cancer.
ORGOVYX, which has previously been given priority review, is the first and only oral gonogen-releasing hormone (GnRH) agent to treat advanced prostate cancer.
approval is based on data on the effectiveness and safety of orGOVYX's Phase 3 HERO study of patients with advanced prostate cancer, which is expected to be available in January 2021.
in the Phase 3 HERO study, ORGOVYX reached the primary clinical endpoint and achieved a continuous testosterone inhibition (95% confidence interval of 95% of the confidence interval of 96.7% of male patients within 48 weeks) of descession levels (-lt;50 ng/dL) 94.9-97.9); In contrast, 88.8 per cent (95 per cent CI: 84.6-91.8) of male patients treated with the current standard of care, acetate bright propylene reilin injections.
, from AbbVie, requires injections every three months, and other treatments for advanced prostate cancer usually require implants to be implanted under the skin.
advantages and clinical efficacy of ORGOVYX are superior to those of Lupron.
In addition, ORGOVYX achieved several key secondary endpoints, including testosterone inhibition of descending levels on days 4 and 15 (56% to 0% and 99% to 12%) on days 4 and 15, respectively, and significant inhibition of testosterone on the 15th day (78% to 1%).
ORGOVYX can reduce prostate-specific antigens (PSA) by an average of 65% on the 15th day and 83% on the 29th day.
in one sub-study, 55 percent of male patients treated with ORGOVYX achieved normal testosterone levels or returned to baseline levels within 90 days of discontinuation of treatment.
orGOVYX did badly at a crucial secondary finish, with a worse survival rate than Lupron after 48 weeks.
In the subgroup of metastatic prostate cancer patients, 74 percent of patients treated with ORGOVYX survived within 48 weeks and had no deglytic resistance, compared with 75 percent of patients treated with acetate.
it is worth noting, however, that ORGOVYX beat the rate of bright propylene acetate in major cardiovascular events, showing a 2.9% incidence, while the incidence rate in the acetate bright propylene reilin treatment group was 6.2%.
, in the ORGOVYX group, at least 10% of male patients reported the most common adverse events: hot water, musculoskeletal pain, fatigue, constipation and mild and moderate diarrhea.
Ami Fadia, an analyst at SVB Leerink, said the advantages of security incidents were an important reason Myovant could position ORGOVYX as a more attractive option for doctors.
ORGOVYX is an oral GnRH-like antagonist that blocks GnRH-like and reduces testosterone production, a hormone known to stimulate the growth of prostate cancer, while acetate is effective by repeatedly attacking the subject to desensitize it.
January 2019, the drug was first approved in Japan for the treatment of uterine fibroids in the same way that it lowers testosterone in men as it reduces estrogen and progesterone in women.
orGOVYX's U.S. FDA application for PDUFA for the treatment of uterine fibroids is set for June 1, 2021, and plans to submit a new drug application for endometriosis to the FDA and European drug regulators later in 2021.
source: FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer