FDA Accepts sNDA for Darolutamide Plus ADT in mHSPC

[Heykm01]

targetedonc.com/view/fda-ac...

Any guesses on how long approval might take?

[Hidden]

I agree 100%! I was diagnosed in 2015 and been metastatic for 2.5 years now and on Lupron since then. I quit Zytiga 6 months because I hated it. My wife and I decided to take a break from ADT because my recent dexa bone scan revealed that I have developed osteoporosis after only 2 years. I could that my bones were becoming damaged. I have been faithful to weight bearing exercise, taking calcium with vitamin D. I am looking forward to break.

I

[duckcalldan]

It will be interesting to find out. I started ADT 4 weeks ago, and I used the ARANOTE phase 3 results to encourage my MO to approve Orgovyx + Nubeqa as my doublet combo. I had a BAD reaction to prednisone many years ago so I wasn’t thrilled about doing the lupron, abitaterone & pred trio. Luckily my insurance approved Nubeqa ($14K/month!) and Orgovyx is coming free from the manufacturer. SEs are mild so far, mainly mild/moderate hot flashes and constipation.

[vintage42 in reply to duckcalldan]

"... I used the ARANOTE phase 3 results to encourage my MO to approve Orgovyx + Nubeqa as my doublet combo..."

My urologist and my MO say that they can approve it by submitting an application for a waiver to the triplet requirement, but since I have not justification for the waiver, they say that insurance will not approve it.

But how do they know until they try? I am going to push for it again, especially since the FDA has accepted a supplemental new drug application (sNDA) for Nubeqa in doublet.

[duckcalldan in reply to vintage42]

It was denied at first but appeal was approved by my plan ) Molina Marketplace). I was pleasantly surprised.

[Concerned-wife]

my husband’s Medicare drug plan has been covering it for this. The dr had to submit a request for approval

[dhccpa in reply to Concerned-wife]

Good to know. Submit to Medicare in advance? I wasn't sure Medicare did pre-approval. Or was this submitted to you Plan D pharma plan?

[Concerned-wife in reply to dhccpa]

Dr submitted info to Part D plan. WellCare. He has not had chemo

[dhccpa in reply to Concerned-wife]

Thanks. I have Wellcare as well.

[Mjex]

WellCare denied my claim because I was Hormone sensitive and not taking Docetaxel

[Yzinger]

reading the article but i am still not understanding. What does this do for us using Nubeqa?

[Heykm01 in reply to Yzinger]

If you're already taking Nubeqa and getting it covered, this won't do anything new for you. But for newly diagnosed MHSPC patients, the only approved therapy taking Nubeqa is with Docetaxel (i.e. triplet). If Bayer is successful in getting the above approved by the FDA, it should allow quick and standard approvals of insurance coverage for the Nubeqa+ADT combo, without the requirement for Docetaxel.

[Yzinger]

Got it. Thanks so much for reply