Orgovyx (relugolix) ADT pills will be available in January 2021

[Tall_Allen]

Sometimes it takes a while for a drug manufacturer to ramp up production and get it into wide distribution. Myovant is predicting Orgovyx (relugolix) will be available next month, according to their website. An internet site says Orgovyx carries a list price of $2,313 per bottle containing 30 pills (ouch!). No info on which drug plans will cover it, but there is a cost-assistance program, and there is a 2-month free trial.

orgovyx.com/

There is a known side effect on the electrical activity of the heart. Here is the full prescribing info:

myovant.com/wp-content/uplo...

[SPEEDYX]

Thats great...I have to check with MO if he will start right away.Iam due for shot in February also if insurance will cover

[StayingOptimistic in reply to SPEEDYX]

I am also due in Feb. please keep us posted. Thanks

[SPEEDYX in reply to StayingOptimistic]

I will ....I have an email to insurance first and sending on to my MO at MSK

[Mjex in reply to SPEEDYX]

Who is your MO? I am at MSK, Manhattan.

[SPEEDYX in reply to Mjex]

Dr McHugh...at commack but he is also in NYC

[dhccpa in reply to SPEEDYX]

Please keep us posted. By the time my last Lupron shot wears off, I'll be on Medicare.

[SPEEDYX in reply to dhccpa]

Will do

[6357axbz]

Thanks

[StayingOptimistic]

Thanks, TA. Do you think it will have the same efficacy as Firmagon? I am doing well on Firmogon but hate the side effect of the injection site. It lasts at least 10 days for me while being in pain.

[Tall_Allen in reply to StayingOptimistic]

Like Firmagon, it's a GnRH antagonist, so I expect the same efficacy.

[GoBucks]

My concerns: 1) Lupron has been around for years. We know the short term and long term side effects. This is a new drug. Clinical trial, yes, but for how long? Do we really know long term effects, especially cardiac related. 2) Financial. For us Medicare guys Lupron is a shot-paid for by Part B. Pills are a Part D, part of the drug plan. Specialty meds have large copays. My Abiraterone is already expensive. I don't need another. 3) If your PSA is <0.01 taking Lupron and Abiraterone, do you want to mess with success and change drugs?

[Tall_Allen in reply to GoBucks]

Good points! You are right - the HERO RCT of relugolix only had 48 weeks of follow-up - we have no idea about side effects that may be cumulative over time. Interactions with other drugs (like abiraterone or enzalutamide) have not been tested. Nor do we know much about its castration-resistance natural history. I agree about the financial toxicity too.

I think the big advantages of Orgovyx are that it starts working immediately and that testosterone returns quickly afterwards. That means it may be particularly useful in certain situations:

• for men newly diagnosed with metastases who are concerned that the initial testosterone boost from a GnRH agonist (like Lupron or Eligard) might aggravate symptoms. It replaces temporary early Casodex or Firmagon, and can be followed with a GnRH agonist injection.

• for men using ADT as an adjuvant therapy to radiation - quicker lead-in period and quicker testosterone return afterwards.

• for men on intermittent ADT (or BAT) - quicker start of the "on" cycle and quicker QOL return at the start of the vacation.

[dhccpa in reply to Tall_Allen]

I read an article yesterday that it bettered Lupron in maintaining castration but was about equal in preventing castration resistance. I didn't quite get the distinction. If that rings a bell, can you explain? If not, I'll try to clarify later. Thanks.

[Tall_Allen in reply to dhccpa]

Both drugs cause chemical castration - negligible testosterone. Castration prevents the androgen receptor on prostate cancer cells from getting activated. Eventually, the androgen receptor becomes resistant to castration - it gets activated in spite of negligible testosterone.

[dhccpa in reply to Tall_Allen]

Thanks that makes perfect sense. Let me re-read the article I read and see if I can figure out what threw me.

[GeorgeGlass in reply to Tall_Allen]

Do you think they can negatively affect the gut microbiome or reduce the effectiveness of other supplements, vitamins or food nutrition since they are going into your belly with the other stuff? Gut microbiome is essential to immunity and general health, not to mention abdominal comfort of lack there of.

[Tall_Allen in reply to GeorgeGlass]

I have no idea.

[tallguy2]

Thanks for posting this. Some major cancer centers and my urologist have no Lupron available due to a nationwide shortage; only Eligard was available to me last week. This will give doctors another tool in their toolkit.

[Runner4000]

Very helpful information. Do Part D insurance companies update their covered drug list just once a year or is that an ongoing process?

[Blueslover]

Look forward to it

[wilcoxsaw]

I spoke to the manufacturer of Orgovyx this morning. I also spoke to Optum Rx, my speciality drug supplier through my Medicare supplement, Blue Cross PPO. Orgovyx is the brand name for relugolix.

The manufacturer said the drug will become available on a limited basis to limited pharmacies sometime in January. There is a website that the oncologist will need to go to to get further information about availability and where to send the prescriptions. Each drug plan has its own formulary so the manufacturer could not quote cost.

Optum RX has relugolix listed in their formulary for my drug plan as a tier 3 drug. My copay would be $50 for a 30-day Supply, $150 for a 90 day supply.

As TA mentioned this drug has the potential to cause some cardiac arrhythmias. But if you look at the side effect profile of the other ADT drugs they have the same potential. The studies to date indicated a 54% reduction of cardiac toxicity with this drug vs Lupron.

[GeorgeGlass in reply to wilcoxsaw]

I do not get the heart impact during hot flashes, while taking the orgovyx, like I did with Lupron. However, I get other side effects with this orgovyx, which I did not get with Lupron. I just posted a question on this site about this topic. Let's see if anyone replies.

[Guber]

estrogen patch, no side effects, no pain, inexpensive

[GeorgeGlass in reply to Guber]

Have any comparison studies been done for estrogen patches vs Lupron//ADT etc?

[Tall_Allen in reply to GeorgeGlass]

Yes:thelancet.com/journals/lanc...

[markoch26]

Hi Allen, that's great news to the advanced survivors. Hopefully, the oral type is as effective as the ADT shots. I don't know when it will get to Taiwan. I guess the urologists or oncologists in Taiwan have never heard of this oral drug.

[Tall_Allen in reply to markoch26]

It's been approved in Japan for uterine fibroids for a few years, only off-label for prostate cancer there.

[Hidden]

TAIs it ADT??

Merry Christmas.

[Tall_Allen in reply to Hidden]

Yes. Similar to Firmagon in the way it reduces testosterone. But a daily pill, instead of an injection.

[Hidden]

Thanks TA

[Kevinski65]

Sometimes there's combo trials using 2 drugs. You should look into it. Are u still working?