FDA Approves Apalutamide (Erleada) for mHSPC

FDA Approves Apalutamide (Erleada) for mHSPC

Nieprzeczytany postautor: zosia bluszcz » 19 wrz 2019, 01:06


BREAKING NEWS: FDA Approves Apalutamide (Erleada) for the treatment of metastatic hormone-sensitive prostate cancer
| Prostate Cancer Foundation

September 18, 2019 –
Last night the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for the treatment of metastatic hormone-sensitive (aka, “castration-sensitive”) prostate cancer (mHSPC).
Apalutamide has previously received FDA-approval for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).

PCF funded the initial synthesis of apalutamide at UCLA by chemist Michael Jung, PhD, in collaboration with prostate cancer physician-scientist Charles Sawyers, MD (now at Memorial Sloan Kettering Cancer Center).

mHSPC refers to men whose prostate cancer has spread to areas of the body outside of the prostate itself, and who are responsive to testosterone-lowering agents. This may refer to men who have had prior surgery or radiation and recurred, or men who were initially diagnosed with disease that was already metastatic (outside the prostate). Patients who are “hormone-sensitive” may have previously received androgen deprivation therapy (ADT) for a certain amount of time, but their cancer has not yet developed resistance to ADT.

This approval is based on results from the randomized phase 3 TITAN clinical trial, which was presented at the 2019 American Society of Clinical Oncology (ACSO) Annual Meeting, held in June, and published in the prestigious medical journal, The New England Journal of Medicine.

The TITAN trial, led by PCF-funded investigator Dr. Kim Chi, MD, of the Vancouver Prostate Centre, tested the addition of apalutamide versus placebo, to ADT in 1,052 men with mHSPC.
Patients on this trial could have previously received ADT for no more than 6 months for mHSPC or no more than 3 years if used as adjuvant therapy for localized prostate cancer, and were not on ADT at the time of disease progression and trial enrollment.
Patients could also have previously received docetaxel chemotherapy for no more than 6 cycles, and could not have progressed on that treatment.

Compared with a placebo, the addition of apalutamide to ADT significantly reduced the risk of death by 33%, and reduced the risk of radiographic disease
progression (tumors growing on scans) or death (whichever came first) by 52%.
Apalutamide also significantly delayed the average time to PSA progression, use of chemotherapy, and pain progression.
Apalutamide was shown to prolong survival of patients with both low and high volume metastatic disease.
The treatment combination of apalutamide and ADT was considered tolerable, and quality of life in patients receiving apalutamide was similar to those receiving placebo in addition to ADT.
Adverse effects that were higher in patients receiving apalutamide vs placebo included rash (27% vs. 8.5% of patients), hypothyroidism (6.5% vs. 1.1% of patients), and fractures (6.3% vs. 4.6% of patients).


https://www.pcf.org/news/breaking-news- ... 0190918fda




FDA approves apalutamide for metastatic castration-sensitive prostate cancer |
https://www.fda.gov/drugs/resources-inf ... ate-cancer
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Re: FDA Approves Apalutamide (Erleada) for mHSPC

Nieprzeczytany postautor: kemoturf » 19 wrz 2019, 09:57

Tylko w FDA jest w USA.
Nam to raczej nie grozi :(


Praktycznie zawsze nowy lek/nowe zastosowanie leku najpierw zatwierdza FDA, potem EMA a potem poszczegolne kraje decydują czy je stac na wprowadzenie leku na listę lekow refundowanych.
Polska, niestety, pozostaje na ogół w ogonie...
-zb
Ur. 1964. 03'2013 PSA - 5.07ng/ml; X'2013 - 12,06ng/ml, pierwsza biopsja negatywna; XI'2013 druga biopsja negatywna; V'2014 PSA - 52.06ng/ml; VI'2014 - trzecia biopsja, Adenocarcinoma solidum GS (5+5) w prawym płacie; VI'2014 TK, scyntygrafia, bez ognisk, RM 2cm zmiany NPL w strefie obwodowej prostaty w prawym płacie; koniec VI'2014 radykalna prostatektomia Adenocarcinoma GS 9 (4+5), komórki raka w naczyniach i nerwach, pT2b, margines ujemny 0,1mm; VIII'2014 PSA po operacji 7ng/ml; PET-CH - przerzuty do węzłów; IX'2014 - początek hormonoterapii Zoladex; X'2014 r IMRT węzłów w miednicy i loży 50Gy 25 frakcji; XI'2014 PSA 0,04ng/ml, I'2015 PSA 0,04ng/ml, II'2015 PSA 0,03ng/ml, III'2015 PSA 0,02ng/ml, VI'2015 PSA 0,04ng/ml, V'2015 PSA 0,03ng/ml, VI'2015 PSA 0,04ng/ml, VII'2015 PSA<0,01ng/ml, IX'2015 PSA<0,01ng/ml, XI'2015 PSA<0,01ng/ml, XII'2015 PSA 0,002ng/ml, II'2016 PSA 0,005ng/ml, wit. C dożylnie 2x25g, IV'2016 PSA0.000 ng/ml, wit. C dożylnie 4x25g, V'2016 PSA 0.000ng/ml, VII'2016 wit. C dożylnie 4x25g, VIII'2016 PSA 0,000ng/ml, kontynuacja suplementacji i Zoladexu, XI'2016 0,000ng/ml, II'2017 0,000ng/ml, badanie CTC - 1350/ml, 3 x kurkumina i 3 x salinomycyna dożylnie, V'2017 0,000ng/ml, CTC - 300/ml, VIII'2017 0,000ng/ml, 3 x kurkumina i 3 x salinomycyna dożylnie, I 2018 CTC 1800/ml, III 2018 PSA 0,000ng/ml, Zoladex STOP, wlewy 4 x Artesunate i 2 x Salinomycyna, CTC 850/ml V 2018 PSA 0.000 ng/ml Testosteron 162 ng/dl, wlewy 2 x Artesunate i 4 x Salinomycyna, VIII 2018 PSA 0.002 ng/ml Testosteron 924 ng/dl, CTC 100/ml, 4 x Artesunate i 2 x Salinomycyna, XI 2018 PSA 0,029, I 2019 PSA 0,079, II 2019 PSA 0,092 - 11 mcy bez HT, II 2019 CT - brak podejrzanych ognisk, powiększona głowa trzustki 55x45, III 2019 PSA 0,186, V 2019 PSA 0,41, VI 2019 PSA 0,52, VI 2019 PET PSMA F18, wznowa 6 mm w loży po pęcherzyku nasiennym, SUV 2,2, IX 2019 PSA 0,88, Bicalutamid, X 2019 PSA 0,26
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