Yonsa vs Zytiga: Why would anyone even... - Advanced Prostate...

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Yonsa vs Zytiga

JLS1 profile image
JLS1
16 Replies

Why would anyone even want to take Zytiga now that Yonsa has been FDA approved?!

"The Yonsa formulation of Yonsa is developed to have a smaller overall particle size. In prior studies, the fine particle size was found to increase dissolution rates and oral bioavailability while decreasing the effects of food on treatment efficacy. In the phase 2 study, the 500-mg dose of Yonsa had similar absorption as the 1000-mg dose of Zytiga."

"Yonsa was administered with methylprednisolone at 4 mg and Zytiga was given with prednisone at 5 mg."

"Four patients had a serious AE in the Yonsa group compared with 7 in the Zytiga arm, two of which led to death (prostate cancer progression and myocardial infarction)."

curetoday.com/articles/fda-...

FDA Approves Combination Treatment for Metastatic Prostate Cancer

The Food and Drug Administration (FDA) approved a new formulation of Yonsa (abiraterone acetate) in combination with methylprednisolone as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC), according to Sun Pharma, the company commercializing the treatment.

BY Silas Inman

PUBLISHED May 24, 2018

The Food and Drug Administration (FDA) approved a new formulation of Yonsa (abiraterone acetate) in combination with methylprednisolone as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC), according to Sun Pharma, the company commercializing the treatment.

The approval was based on findings from a phase 2 study comparing the Yonsa formulation of Yonsa to the original, Zytiga, which was approved in 2011. In the trial, which was known as STAAR, Yonsa demonstrated therapeutic equivalence to Zytiga, based on serum testosterone levels, and both agents showed similar declines in PSA of 50 percent or higher (PSA-50).

“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” Abhay Gandhi, CEO - North America, Sun Pharma, said in a statement announcing the approval.

The Yonsa formulation of Yonsa is developed to have a smaller overall particle size. In prior studies, the fine particle size was found to increase dissolution rates and oral bioavailability while decreasing the effects of food on treatment efficacy. In the phase 2 study, the 500-mg dose of Yonsa had similar absorption as the 1000-mg dose of Zytiga.

The STAAR trial included 53 patients with mCRPC who had not received prior Yonsa, enzalutamide, radium-223, or chemotherapy (unless it was docetaxel one or more year prior to study entry). Patients were randomized in a 1 to 1 ratio to receive Yonsa at 500 mg (four tablets at 125 mg each) or Zytiga at 1000 mg (four tablets at 250 mg each). Yonsa was administered with methylprednisolone at 4 mg and Zytiga was given with prednisone at 5 mg.

Across both arms, approximately half of patients (54.7 percent) had Gleason higher than 7 disease. There were more Caucasians in the Yonsa arm (83.3 percent) than in the Zytiga group (69 percent). The mean time since diagnosis of mCRPC was 2.1 years in both groups and baseline testosterone levels were 7.28 in the Yonsa group and 7.95 in the Zytiga arm (8.4 percent relative difference).

The mean testosterone level at day 9 and 10 was 0.32 (±0.45) in the Yonsa group and 0.29 (±0.29) in the Zytiga arm. The median level at day 9 and 10 was 0.15 with Yonsa and 0.19 with Zytiga. At day 28, patients in both arms had a mean testosterone level of 0.10 and the mean was 0.22 (±0.26) and 0.25 (±0.30) in the Yonsa and Zytiga groups, respectively. At day 84, the median was 0.10 with Yonsa and 0.15 with Zytiga.

PSA-50 was observed in more than 65 percent of patients in both arms of the study. The least square mean difference in serum PSA level between Yonsa and Zytiga at day 28 was -15.13. At day 84, the difference was -18.80.

Overall, fewer patients experienced treatment-emergent adverse events (AEs) in the Yonsa arm compared with Zytiga (75 percent vs 82.8 percent, respectively). Grade 3 or higher AEs were experienced by 16.7 percent of patients in the Yonsa arm and for 17.2 percent in the Zytiga group. Four patients had a serious AE in the Yonsa group compared with 7 in the Zytiga arm, two of which led to death (prostate cancer progression and myocardial infarction).

Yonsa (Zytiga) was initially approved as a treatment for men with mCRPC following chemotherapy. It subsequently gained approval for use prior to chemotherapy. In February 2018, Zytiga was approved in combination with prednisone for patients with metastatic high-risk castration-sensitive prostate cancer.

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16 Replies
gusgold profile image
gusgold

Plenty of guys...it looks like Yonsa is approved for mCRPC...it is now possible to obtain Zytiga with hormone sensitive cancer...my Doc says you don't even have to be matastatic and he prescribes Lupron/Zytiga to most patients

in reply to gusgold

Any trials with all 3 mechanisms: Zytiga, Lupron, and Chemo?

leswell profile image
leswell

Dear JLS1 from “jls2”, Your post 4 mo ago brought forth so much concern and sympathy. Is it okay to ask how your husband is today? What are his current liver enzymes? Are you encouraged? And, relating to this post, are you two considering Yonsa for him?

You can understand our interest having been on Zytiga for two weeks. I fear that if I bring up any more deviations from the norm at Leswell’s next appointment we may be dumped. We’re already having one piece of toast and coffee an hour prior to Zytiga. Sinful, right? So we’ll await the next word from “god”, the almighty PSA. Not to be impertinent. You are an indefatigable researcher with whom I could never compete. I want your husband and mine to outwit, which is to say outlive, this disease. I’m sorry, but sometimes I agree most with Nal who says if we get insurance approval of only one drug at a time, those drug companies are killing all of us slowly and softly. (I’m not a doctor nor do I deign to speak for N!). Please tell us how your husband is doing now. Maybe I’ve missed some post or reply of yours. Mrs. S

JLS1 profile image
JLS1 in reply to leswell

Hello leswell (jls2 :-) ) - My apology for not responding earlier. I've been more than overwhelmed lately. My mother passed away in March from ovarian cancer, leaving behind my 92 yr old dad who she was taking 100% care of, and he's not able to be on his own, and they were living hundreds of miles from us. (Mom was diagnosed stage 4 ovarian, a couple weeks after my husband was diagnosed st 4 prostate cancer - early winter 2017 - both were a surprise/shock). During this time my husband went through a very 'scary' period where his blood test results disqualified him from any more treatments of the combo chemo he needed (he only had 1 infusion of carboplatin/jevtana). His bone pain was gettting worse, so while he was waiting for the benefits of the 10 radiation treatments to kick in (lower spine, L1-L4) he had to keep upping the opoid pain meds, which made him basically comatose,in bed all day - same position, and vomiting every once in a while. That was horrible!! Dr. started him on Lynparza at the beginning of March (he has the BRCA gene - somatic). Once on Lynparza, his pain quickly lessened (probably a combo of the Lynparza and the radaiation treatments kicking in) and at the same time his blood tests showed his liver numbers were back within normal range (yay!!). Once his pain lessened, he immediately went off all the opoids and other meds he was taking for the side effects of the Lupron and opoids, and the side effects from those 'side effect' drugs!! That caused difficult withdrawal side effects for about 1-1/2 weeks. Almost immediately after stopping the opoids, my husband came back!! So at that point, he only needed the Lynparza - a miracle drug! A couple weeks ago he had a bone scan and CT scan which gave mixed results, but our MO felt overal positive. The Lynparza has been working in soft tissue, but his PSA was up, and bone scans were showing activity. So our MO just added Zytiga to his Lynparza. He will have a blood test next week to see how this is going. Most importantly, he's been much happier - up and about - walking the dog in the morning (carefully! and not too far) and just feeling overall better - almost 'normal'. He's still anemic (a side effect of the Lynparza - almost needed a transfusion a couple times), so he gets a bit out of breath when being more active, but this, too, has been slowly improving.

We need LOTS of prayers with fingers crossed for this Lynparza + Zytiga combo to work well, for a loooong time, please!!

I hope your husband is doing well and his next test results show he's responding well to the Zytiga. Prayers for all of us ..... Hoping to buy enough time with these drugs until a better treatment becomes available so we can win this fight!!

in edit:

Our Prostate Cancer team at U of C has been Wonderful!! We've been very impressed and thankful for how quickly they work with our insurance CO to get approval for all the meds.

leswell profile image
leswell in reply to JLS1

Dear JLS1, Prayers with fingers crossed is what you have right now! Your reply is overwhelming. We send our sincere sympathy about your mother’s death. How is your dad doing?

We are rejoicing with you about your husband’s improvement! (I need to look up Lynparza). Please, let’s stay in touch about our husbands’ ongoing results from Zytiga. Walking the dog is an encouraging sign. Greet your husband and give that dog a hug from me. Where to start? You’ve been through the trials of Job. Be strong as you have been for so long. You have the prayerful support of so many on this site, us included.

My mom died a month from 104 yrs and four months before my husband's shocking diagnosis. Our parents were nearly our “children” for the twenty years of Les’s retirement. We miss them but, although we chose not to have children ourselves, are not entirely alone and bereft. Les’s sisters and husbands, my brothers and wives plus nephews, nieces and even former students couldn’t be more supportive. I trust you and your husband are equally rich in family and friends.

Thank you for writing at such a difficult and busy time. I only wish I had something more informed, concrete, and helpful to contribute. In any case, you can be sure I will write again when I either have learned more or feel “inspired”.

With earnest prayers for peace of mind and for your husband’s physical improvement,

Jan and Les

leswell profile image
leswell in reply to leswell

P.S. Oh yes, Lynparza for use with abiraterone for mCRPC. PARP inhibitor Olaparib, usually for ovarian cancer. See 2018 ASCO recommendation. Current trials, I believe. Good for you. You probably knew about that also because of your dear mother, right?

I’ll get educated yet. Mrs. S

cesanon profile image
cesanon

They are both abiraterone acetate, correct? The difference is particle size?

What is the difference in price?

Will the two drugs have different restrictions on use?

in reply to cesanon

same question - price difference, or is possibly inclusion in the "formulary" an issue?

Abiraterone is off patent in October, although no generic is ready for market, AFAIK.

cesanon profile image
cesanon in reply to

Oh. Ok then this is an improved generic. But at a non-generic price.

I think we are going to have insurance approval problems with this.

Insurers won't want to pay the premium for the new and improved.

Am I getting this right guys?

Am I overlooking anything?

I guess a lot is going to turn on how much of a premium they are going to charge for it.

If the pharma doesn't get too greedy, maybe the insurers won't get too penurious.

in reply to cesanon

Oh no. I just found out about this here, yesterday.

The company would apply for and get new IP protection for anything that they could argue was different and better. Which this appears to be.

This is not a "generic" drug, nor is abi just yet.

Litlerny profile image
Litlerny

Agree with gusgold. The guys you are still hormone sensitive but high risk qualify for Zytiga, but not for Yonsa. , which right now is only approved for men with mCRPC.

leo2634 profile image
leo2634

As far as Zytiga at least for me it has worked well beyond what I expected. Lowered my PSA from 14.7 to 0.1 along with Eligard in one month. I'm not saying it is the wonder drug but it did work wonders on me. It took a Lot of time and aggravation to get me on it both with cost and apprehension I thank God everyday for my Doctor and his staff for getting me the financial assistance to pay for it too. If it's the same medication in a smaller does I'm sticking with Zytiga.

TommyTV profile image
TommyTV

I’ve been on Zytiga 1000mg and 5mg Prednisone for 6.5 years now, along with Zoladex. It’s been remarkable for me. PSA @ dx 571, dropped to 0.2 within 8 weeks, immeasurable @ 12 weeks, where it’s remained. My seven Mets have been pain free (unless I antagonise them) and I feel pretty good, apart from severe muscle wastage, which has left me somewhat disabled. Small price to pay though😃

joancarles profile image
joancarles in reply to TommyTV

Every time I read your publications, with such a good response to Zytiga, it gives me a lot of hope. I've been with Zytiga for 9 months and it's working well. I hope to follow your steps. To follow

The trial was in 2014? Something is strange with this.

ncbi.nlm.nih.gov/pubmed/291...

Oh no. Its November 14, 2017. Ok.

But still, not to have heard anything about this prior to its approval... A tiny bit weird.

Dhenzkie profile image
Dhenzkie

Hi is Yonsa already available in the US?

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