Orgovyx (Relugolix) czyli leuprorelina w tabletkach

Orgovyx (Relugolix) czyli leuprorelina w tabletkach

Nieprzeczytany postautor: zrebie » 20 sty 2021, 18:50

Hmmm, nowość w pigułce?

https://youtu.be/DkGi_04RLZM



Dodane przez -zb:

Orgovyx: New FDA Approved Hormone Therapy | 2020: The Year In Review | Mark Scholz, MD

Prostate Cancer Research Institute

Orgovyx (relugolix) is the latest frist-generation hormone therapy to be FDA approved for the treatment of advanced prostate cancer.
It comes in pill form and is thus more convenient than similar drugs like Lupron.
Early data also suggests that Orgovyx may be safer than the alternatives in patients with heart problems.
31/01/2019 - RM kręgosłupa L liczne problemy kostne Th11 i L4/5 oraz w prawym dole biodrowym najprawdopodobniej masa węzłowa wielkości 43x24x26.
08/02/2019 - USG jamy brzusznej (potwierdzenie - w podziale naczyń biodrowych prawych masa węzłowa o wym 43x27mm
18/02/2019 - TRUS - GK o obj 18cm3 (28x47x28 mm), prawy płat w całości zajęty przez lite nieco niejednorodne ognisko z drobnymi zwapnieniami, śr 26mm, prawy pęcherzyk nasienny: prawy szer 22mm, lewy 18mm.
15/02/2019 PSA 231 ng/ml , PSA wolne >50 ng/ml
20/02/2019 scyntygrafia kości liczne metastasis (8), Radiofarmaceutyk: 99nTc-MDP; Aktywność: 700MBq
21/02/2019 PSA 270 ng/ml fPSA >50ng/ml F/T>19
22/02/2019 Biopsja stercza, wynik z 27.02.2019 - T4N1M1 Gleason 8(4+4)
25/02/2019 Bikalutamid 50 Start
5/03/2019 PSA >100 ng/ml , T 4,41ng/ml
6/03/2019 I Docetaksel
14/03/2019 Reseligo 10,8 + Zomikos, PSA 283ng/ml
24/03/2019 Bikalutamid stop
27/03/2019 PSA 192 ng/ml
28/03/2019 II Docetaksel
3/04/2019 PSA 140 ng/ml; T 0,09ng/ml
17/04/2019 PSA 60,3 ng/ml; 0,08ng/ml
18/04/2019 III Docetaksel
8/05/2019 PSA 45 ng/ml; T: 0,07mg/ml
9/05/2019 IV Docetaksel
16/05/2019 II Zomikos
29/05/2019 PSA 30,2 ng/ml T: 0,18 ng/ml
30/05/2019 V Docetalsel
11/06/2019 PSA 74 ng/ml T: 0,42 ng/ml Bicalutamid start
21/06/2019 PSA 36,6 ng/ml T:0,13 ng/ml Bicalutamid stop
24.06.2019 VI Docetaksel
16/07/2019 PSA: 28,9ng/ml T:0,35 ng/ml
13/08/2019 PSA:18,9ng/ml T:0,08 ng/ml
22/08/2019 PET PSMA F-18 - liczne zmiany w kosciach; węzły zmniejszone
31/08/2019 PSA:21,12ng/ml T:0,43 ng/ml ; Bicalutamid 50 start
02/09/2019 PSA:18,2ng/ml T:0,35 ng/ml
05/09/2019 III Reseligo 10.8
17/10/2019 PSA: 6,71ng/ml T:0,16ng/ml
24/10/2019 PSA: 8,42ng/ml T:0,48ng/ml
29/10/2019 PSA: 8,61ng/ml T:0,09ng/ml
15/11/2019 PSA: 7,19ng/ml T:0,11ng/ml
21/11/2019 Reseligo 10.8
06/12/2019 PSA: 11,4ng/ml T:0,19ng/ml
11/12/2019 - PET PSMA F18 (3 aktywne zmiany)
30/12/2019 PSA: 6,53ng/ml T:0,12ng/ml
07/01/2020 PSA: 7,75ng/ml T:0,18ng/ml
13/01/2020 Scyntygrafia (pokazuje nową zmianę)
15/01/2020 PSA: 13,1ng/ml T:1ng/ml
23/01/2020 Zomikos
27/01/2020 PSA: 15,95ng/ml T:0,36ng/ml
18/02/2020 PSA: 22,5ng/ml T:0,03ng/ml
20/02/2020 Reseligo 10.8
4/03/2020 PSA: 50,8ng/ml T:0,29ng/ml
10/03/2020 TALAPRO-2 start (Enzalutamid +Talazoparib/Placebo)
24/03/2020 PSA: 15,73ng/ml T:0,27ng/ml
7/04/2020 PSA: 10,5ng/ml
02/06/2020 PSA: 9,9ng/ml
30/06/2020 PSA: 8,41ng/ml
22/07/2020 PSA: 7,26ng/ml T:0,41ng/ml
25/08/2020 PSA: 5,18ng/ml
22/09/2020 PSA: 4,63ng/ml
28/11/2020 PSA: 3.72 ng/ml
28/12/2020. PSA: 3,68 ng/ml
9/03/2021 PSA: 2,65 ng/ml (przechodzę na tryb co 2 miesiące w badaniu TALAPRO-2)
6/04/2021 PSA: 2,39 ng/ml T:0,19ng/ml

Mój wątek: viewtopic.php?t=3212
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Re: Orgovyx

Nieprzeczytany postautor: leonardo556 » 20 sty 2021, 21:34

Orgovyx może się przydać do łatwego i szybkiego obniżenia testosteronu.

Zastanawiałem się w jaki sposób można przerwać monoterapię antandrogenową. Odstawienie bikalutamidu nie redukuje radykalnie poziomu testosteronu.
Orgovyx można by wtedy zastosować doraźnie.
ur. 1956 PSA 5,2 Gleason 7 (3+4) sierpień 2013
RP Da Vinci 9 październik 2013 , pT3a pN0 (0/13) R0, Gleason: 4(75%) + 3(25%) = 7
PSA - 0,003 - 28.11.2013, 28.11.2014
PSA - 0.008, 0.012, 0.018 odpowiednio styczeń, lipiec, październik 2015
PSA - 0.044 22 luty, 0,038 13 lipiec 2016, 0,103 23 listopad 2016, 0,476 14 lipiec 2017, 0,55 październik 2017
wycięcie 50 węzłów Da Vinci , UICC: pT3a pN1 (1/63) R0, PSA 0,31 październik 2017, PSA 0,7 marzec 2018
IMRT TrueBeam, 22x2,6 Gy = 57,2 Gy, maj 2018 + bikalutamid 50 mg (kwiecień ,maj, czerwiec)
PSA - 0,341 - 0,310 - 0,234 - 0,212 - 0,188 - 0,154 (15.03.2019) - 0,142 (31.07.2019) - 0,148 (19.12.2019)
0,248 (19.02.2020) - 0,337 (21.04.2020) - 0,466 (03.07.2020) - 0,518 (27.07.2020) - 0,947 (10.11.2020)
IMRT Truebem 3x5=15 Gy - naświetlanie prewencyjne ginekomastii - 12.11.2020, monoterapia bikalutamidem 50 mg
PSA - 1,04 (10.12.20) - 0,127 (13.04.21) - 0,126 (25.06.21) - 0,159 (30.08.21), zwiększenie dawki do 100 mg, 0,08 (05.10.21)
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Orgovyx (Relugolix) czyli leuprorelina w tabletkach

Nieprzeczytany postautor: zosia bluszcz » 21 sty 2021, 08:43

FDA approves relugolix for advanced prostate cancer


On December 18, 2020, the Food and Drug Administration approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc.) for adult patients with advanced prostate cancer.

Efficacy was evaluated in HERO (NCT03085095), a randomized, open label trial in men requiring at least one year of androgen deprivation therapy with either
prostate cancer recurrence following radiation or surgery or newly diagnosed castration-sensitive advanced prostate cancer.

Patients (N=934) were randomized (2:1) to receive relugolix 360 mg oral loading dose on the first day, followed by daily oral doses of 120 mg, or leuprolide acetate 22.5 mg injection subcutaneously every 3 months for 48 weeks.

The main efficacy outcome measure was medical castration rate defined as achieving and maintaining serum testosterone suppression to castrate levels (< 50 ng/dL) by day 29 through 48 weeks of treatment. The medical castration rate was 96.7% (95% CI: 94.9%, 97.9%) in the relugolix arm.

The most common adverse reactions (≥10%) in patients receiving relugolix in HERO were hot flush, musculoskeletal pain, fatigue, diarrhea, and constipation.
The most common laboratory abnormalities (≥15%) were increased glucose, triglycerides, alanine aminotransferase, and aspartate aminotransferase.
Decreased hemoglobin was also observed.

The recommended relugolix dose is a loading dose of 360 mg on the first day followed by a daily oral dose of 120 mg at approximately the same time with or without food.


https://www.fda.gov/drugs/drug-approval ... ate-cancer



ORGOVYX (relugolix) tablets - prescribing information.pdf




A teraz o przewidywanym koszcie zastąpienia implantu z leuproreliną, np. Eligardu, przez doustną leuprorelinę czyli Relugolix (nazwa firmowa - Orgovyx.

Wg producenta leku, firmy Myovant, Orgovyx powinien pojawić się na rynku w styczniu 2021.
Cena hurtowa leku w USA będzie wynosiła USD $2,313 za opakowanie zawierające 30 120 mg tabletek, czyli miesiąc leczenia po pierwszej, potrójnej dozie leku (360 mg loading dose).


Holenderska apteka online, The Social Medwork, przewiduje, że koszt miesięcznego opakowania dla indywidualnego pacjenta będzie wynosił €4,394.00
https://thesocialmedwork.com/orgovyx-relugolix
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AUA 2021 Orgovyx (Relugolix) czyli leuprorelina w tabletkach

Nieprzeczytany postautor: zosia bluszcz » 25 wrz 2021, 13:35

W ramach badania klinicznego
HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer NCT03085095 https://www.clinicaltrials.gov/ct2/show/NCT03085095

przeprowadzono dodatkowy nabór 101 mężczyzn z zaawansowanym CaP aby dokonać oceny czasu przeżycia do momentu, w którym CaP staje się odporny na kastrację podczas 48 tygodni leczenia relugolixem (leuprorelina w tabletkach) lub standardową formą leuproreliny (implant).

Konkluzja: Brak wyższości relugolixu nad standardową leuproreliną jeśli chodzi o czas przeżycia do momentu osiągnięcia odporności na kastrację u mężczyzn z przerzutowym rakiem prostaty






AUA 2021: Castration Resistance – Free Survival With Relugolix Is No Longer Than Leuprolide in Metastatic Prostate Cancer
An analysis of castration resistance – free survival in the HERO trial was conducted.


Practice Update Editorial Team

September 10, 2021—Las Vegas, Nevada

Castration resistance – free survival after 48 weeks of treatment of relugolix was no longer than with standard-of-care leuprolide in men with metastatic prostate cancer.
This outcome of an analysis of castration resistance – free survival in the multinational phase 3, randomized, open-label, parallel group HERO study was reported at AUA 2021, the 116th Annual Meeting of the American Urological Association, from September 10 – 13.

In HERO, Neal Shore, MD, of the Carolina Urologic Research Center, GenesisCare/Atlantic Urology Clinics, Myrtle Beach, South Carolina, and colleagues set out to evaluate the safety and efficacy of relugolix in men with advanced prostate cancer. Men were randomized 2:1 to relugolix 120 mg orally once daily after a single loading dose of 360 mg or leuprolide 3-monthly injections for 48 weeks.

To further characterize the efficacy profile of relugolix, the HERO study randomized an additional 101 men to assess a secondary endpoint of castration resistance - free survival during 48 weeks of treatment.
Castration resistance - free survival is a clinically relevant indicator of disease progression in the final analysis.
Castration resistance - free survival was defined as the duration from the date of the first dose to the date of confirmed PSA progression (defined by Prostate Cancer Clinical Trials Working Group 3) while castrated or death due to any reason, whichever occurs earlier.

Analysis of the HERO trial was conducted in the cohort with metastatic disease as well as in the overall modified intention-to-treat population.
Overall, 1074 men with advanced prostate cancer (n=717 relugolix, n=357 leuprolide) and 434 men with metastatic disease (n=290 relugolix, n=144 leuprolide) were included in the analysis of castration resistance - free survival (modified intent-to-treat population). Mean age of men with metastatic disease was 71 years, 29% of whom were older than 75 years of age. Men included in the analysis were from North and South America (28.9% and 6.4%), Europe (37.8%), and Asia/rest of world (26.9%).

At study entry, the most common location of metastasis was bone only (53%). Rates of castration resistance - free survival at week 48 in the cohort with metastatic disease were 74.3% (95% confidence interval 68.6%, 79.2%) and 75.3% (95% confidence interval 66.7%, 81.9%) in the relugolix and leuprolide groups, respectively (hazard ratio1.03 [0.68, 1.57], difference not significan). Results were similar in the overall modified intent-to-treat population. No new safety findings were identified.

Dr. Shore explained that androgen deprivation therapy is foundational treatment for achieving castration levels in men with advanced prostate cancer.
Relugolix is an FDA-approved, oral gonadotropin-releasing hormone receptor antagonist. The agent demonstrated suppression of testosterone to castrate levels in 96.7% of men, superior to leuprolide (88.8%), and 54% risk reduction in major adverse cardiovascular events relative to leuprolide in the phase 3 HERO study.

Dr. Shore concluded that in the HERO study, castration resistance - free survival assessed during 48 weeks of treatment with relugolix was not significantly longer than that with standard-of-care leuprolide in the subgroup of men with metastatic disease or in the overall modified intent-to-treat population.


https://www.practiceupdate.com/c/124132 ... d=20845155
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