Info I received from Myovant Sciences on Orgovyx

[JPnSD]

I went to website Orgovyx.com and then called their info number (833-674-6899) and then got referred to their "Medical Team", which turned out to be a pharmacist. I requested product info and links for clinical studies. They sent me an email with the drug insert as an attachment and a cover letter. I was also told the product is under limited release only through 2 pharmacies (by mail only) US Bio Services and Biologics Specialty Pharmacy. A doctor has to apply for you to be included in the limited release. One strange thing, she told me that she could only send the info on their clinical studies to my doctor??!!! Since when??? Anyone have links to the clinical studies summaries to FDA for approval?

[Tall_Allen]

Sure. Heere's what they published:nejm.org/doi/full/10.1056/N...

[JPnSD in reply to Tall_Allen]

Thank you for sharing that.

[4Rosebud]

look up studies on the cancer.gov site, or just deep dive it on google...they also have new programs looking for volunteers too.

[dhccpa]

Top Secret!

[JPnSD]

The pharmacist called me back and said their Medical Team verified they would only release their clinical study info to a physician. I told them that was unacceptable and to tell their management that if they expected people to trust them enough to pay $20/day and to take their pill for possibly YEARS...they needed full transparency. The silly part of this - there is a summary of the clinical study in the drug insert that was sent to me. Appears they are not even aware of what they are already releasing. Here is the most pertinent portion of their 48-month study:

The safety of ORGOVYX was evaluated in HERO, a randomized (2:1), open-label, clinical study in patients with advanced prostate cancer [see Clinical Studies (14)]. Patients received orally administered ORGOVYX as a loading dose of 360 mg on the first day followed by 120 mg taken orally once daily (n = 622) or received leuprolide acetate administered by depot injection at doses of 22.5 mg (n = 264) or 11.25 mg (n = 44) per local guidelines every 12 weeks (n = 308). Leuprolide acetate 11.25 mg is a dosage regimen that is not recommended for this indication in the US. Among patients who received ORGOVYX, 91% were exposed for at least 48 weeks. Ninety-nine (16%) patients received concomitant radiotherapy and 17 (3%) patients received concomitant enzalutamide with ORGOVYX.

Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. Serious adverse reactions in ≥ 0.5% of patients included myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), hemorrhage (0.6%), and urinary tract infection (0.5%). Fatal adverse reactions occurred in 0.8% of patients receiving ORGOVYX including metastatic lung cancer (0.3%), myocardial infarction (0.3%), and acute kidney injury (0.2%). Fatal and non-fatal myocardial infarction and stroke were reported in 2.7% of patients receiving ORGOVYX.

Permanent discontinuation of ORGOVYX due to an adverse reaction occurred in 3.5% of patients. Adverse reactions which resulted in permanent discontinuation of ORGOVYX in ≥ 0.3 % of patients included atrioventricular block (0.3%), cardiac failure (0.3%), hemorrhage (0.3%), increased transaminases (0.3%), abdominal pain (0.3%), and pneumonia (0.3%).

Dosage interruptions of ORGOVYX due to an adverse reaction occurred in 2.7% of patients. Adverse reactions which required dosage interruption in ≥ 0.3% of patients included fracture (0.3%). The most common adverse reactions ( ≥ 10%) and laboratory abnormalities (≥ 15%), were hot flush (54%), glucose increased (44%), triglycerides increased (35%), musculoskeletal pain (30%), hemoglobin decreased (28%), alanine aminotransferase increased (ALT) (27%), fatigue (26%), aspartate aminotransferase increased (AST) (18%), constipation (12%), and diarrhea (12%).

Table 1 summarizes the adverse reactions in HERO.

I cannot figure out how to cut/paste the summary table without it being scrambled here.