It should either be used following removal of the testicles or along with a gonadotropinreleasing hormone analog. The fda approval of a novel, fineparticle formulation of abiraterone acetate provides a. More than 330,000 patients worldwide, including 1,000. Zytiga abiraterone acetate is a cyp17 inhibitor indicated for the treatment of patients with metastatic castrationresistant prostate cancer and metastatic highrisk castrationsensitive prostate cancer. More than 40,000 men worldwide have received treatment with it, and it is quickly becoming one of. Zytiga can be paradigmshifting for prostate cancer treatment. The phase3 studies conducted with zytiga excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the. Zytiga is an inhibitor of the hepatic drugmetabolizing enzymes cyp2d6 and cyp2c8.
Zytiga approved in the eu for use in the treatment of. On february 7, 2018, the food and drug administration fda approved abiraterone acetate zytiga, janssen biotech inc. Last year european regulators cleared its use as a firstline treatment for advanced prostate cancer, alongside hormone therapy. Zytiga s composition patent expired in december 2016 in the us and generic entry is expected in october 2018. Pharmacokinetic aspects of the two novel oral drugs used for metastatic. Zytiga is used to treat men with prostate cancer that has spread to other parts of the body. Abiraterone acetate is a novel cyp17a1 inhibitor demonstrated to prolong survival in. Might we see generic abiraterone acetate this year. It has since gained approval earlier in the treatment paradigm for use prior to chemotherapy. Regulatory authorities approved abiraterone acetate in 2011 after a. Zytiga 500 mg filmcoated tablets are purple, ovalshaped, filmcoated tablets, debossed with aa on one side and 500 on the other.
Zytiga, used in combination with prednisone and androgen deprivation therapy, was shown to reduce the risk of death by 38 per cent 1. Hypoglycemia severe hypoglycemia has been reported when zytiga was administered to patients with preexisting diabetes receiving medications containing thiazolidinediones including pioglitazone or repaglinide see drug. Zytiga stops production of androgens throughout the body by blocking an enzyme required for their biosynthesis. If patients develop liver problems treatment should be stopped. Zytiga 250 mg tablets are white to offwhite, oval tablets, with aa250 on one side. Meanwhile, stampede showed a 37% benefit with zytiga on overall survival, and on threeyear failurefree survival the benefit of zytiga plus adt was 71%. Prostate cancer zytiga abiraterone acetate is a cyp17. In latitude, zytiga plus adt reduced the risk of death by 38% and radiographic progression by 53%. Patent trial and appeal board invalidated the last remaining patent on abiraterone acetate zytiga, making it possible that generic forms of abiraterone acetate would be available in 2018 at least in the us. Brand zytiga will continue to be covered and can be filled for the patient if he or she meets prior authorization criteria. Janssens zytiga approved for earlier use in prostate. Abiraterone acetate was described in 1995, and approved for medical use in the united states and. The drug, which is orally administered, blocks androgen production by inhibiting cyp17, an enzyme expressed in testicular, adrenal, and prostate tumor tissue. Zytiga 250 mg tablets are available in highdensity polyethylene bottles of 120 tablets.
Janssens zytiga approved for earlier use in prostate cancer. Zytiga abiraterone acetate receives fda approval for. Zytiga is currently approved for use on the nhs before chemotherapy but only after patients have received standard hormone therapy. Horsham, pa april 28, 2011 centocor ortho biotech inc. Zytiga was first approved in 2011 in combination with prednisone for the treatment of men with metastatic castrationresistant prostate cancer following chemotherapy. The fda approval of a novel, fineparticle formulation of abiraterone acetate provide.
Sep 15, 2017 zytiga won fda approval in 2011 and since then, its gone on to become a widely used therapy in castrationresistant metastatic prostatecancer patients. The agency approved abiraterone, in combination with the steroid prednisone, for men with metastatic prostate cancer that is responsive to hormoneblocking treatments also known as castrationsensitive and is at high risk of progressing. Oct 21, 2015 casodex gave out after 9 months, and zytiga had just been approved 1 week prior, so continued on lupron, dropped casodex and started zytiga. Fda approval history for zytiga abiraterone used to treat prostate cancer. Zytiga abiraterone acetate tablets for oral use initial u. The study participants had metastatic, hormonerefractory prostate cancer that has progressed after chemotherapy. There are no novel excipients used in this formulation. First oncedaily, oral treatment for metastatic prostate cancer inhibits androgen production at all three sources. Regulatory authorities approved abiraterone acetate in 2011 after a survival. Avoid coadministration with cyp2d6 substrates with a narrow therapeutic index.
Zytiga has been approved by the fda since 2011 in combination with prednisone for patients with metastatic castrationresistant prostate cancer. Titan could give erleada a fighting chance evaluate. Janssencilag international nv janssen announced today that the european commission ec has approved an extension to the license of the oral, oncedaily medication zytiga abiraterone acetate. Fda approval the fda approval of zytiga was based on a randomized, placebocontrolled, multicenter study in 1,195 subjects. Zytiga 500 mg tablets are available in pvdcpepvcalu blister packs of 60 tablets.
Excess use with caution in patients with a history of cardiovascular disease or with. The approved broader indication for zytiga now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic castrationresistant prostate cancer mcrpc, in adult men who are asymptomatic or mildly symptomatic after failure. The study participants had metastatic, hormonerefractory. Fda expands abiraterone approval for prostate cancer. This new patent covers the methodofuse, specifically the coadministration of prednisone with zytiga, a dosing regimen that was already prescribed in the fda approved product label. Zytiga linked to better quality of life in men with. The recommended dose of zytiga is 1,000 mg taken once a day at least two hours after eating and at least one hour before further food. Because of this risk, zytiga should be used cautiously in patients with a strong cardiovascular history, and patients should be monitored closely for these symptoms. The approval was based on results from a phase 3, randomized, placebocontrolled study showing that abiraterone plus prednisone resulted in a 35% reduction in the risk of death 14.
Yonsa fineparticle abiraterone acetate new formulation. Zytiga is available as tablets 250 and 500 mg and can only be obtained with a prescription. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Nice rejects janssens zytiga for early, aggressive. Zytiga should be used with caution in patients with a history of cardiovascular disease.
Abiraterone acetate, sold under the brand name zytiga among others, is a medication used to treat prostate cancer. There was no evidence of clinically significant differences in psa response or safety between yonsa and zytiga. As a result, zytiga may cause hypertension high blood pressure, hypokalemia low levels of potassium in the blood, and fluid retention. Ecog ps score of 1 and 45% had a history of bone and softtissue metastases. Abiraterone acetate an overview sciencedirect topics. If alternative treatments cannot be used, consider a dose reduction of the cyp2d6 substrate drug. The subjects received either zytiga orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg orally twice daily or placebo once daily plus prednisone 5.
Prescription treatment with zytiga abiraterone acetate. Food and drug administration fda has approved zytiga abiraterone acetate, an oral, oncedaily medication for use in combination with prednisone for the treatment of men with metastatic castrationresistant prostate cancer who have received prior chemotherapy containing docetaxel. June 2, 2014 notice of allowance excerpt from prosecution history of 438 patent 1017 declaration of dr. With this approval, zytiga, in combination with prednisone, may now be. Deforest mcduff, phd mcduff declaration 1018 2011 zytiga approval prescribing information 1019 2015 zytiga prescribing information, coadministration brochure 1020. Uncontrolled hypertension, viral hepatitis or chronic liver disease, history of pituitary or adrenal dysfunction. On may 5, 2014 psa down to 125, june 18, 2014 psa down to 26. Janssen submits supplemental new drug application to u.
Zytiga abiraterone treatment for advanced prostate cancer. Zytiga practicechanging clinical news but is it a home run. Zytiga abiraterone acetate plus prednisone approved for. The us fda originally approved zytiga for the treatment of advanced prostate cancer in 2011 based on a study that enrolled 1,195 men from countries. Internationally, janssen says regulatory exclusivity protects zytiga through september 2022. Jan 31, 2019 zytiga has already set the bar in the comparable latitude and stampede trials. Fda approves abiraterone acetate in combination with prednisone. The european medicines agency decided that zytigas benefits are greater than its risks and recommended that it be approved for use in the eu.
Abiraterone zytiga, a novel agent for the management of. Previous analyses from the trial showed that both zytiga and docetaxel delay disease progression and improve survival when added to standardofcare therapy, so questions remain about which is a better option. Zytiga abiraterone acetate is a cpy17 inhibitor indicated for use in combination with. It is not known if zytiga is safe or effective in children. Prescribers with questions regarding this change may call 1800555clin 18005552546, monday through friday, 8 a. Hypokalemia, fluid retention, and cardiovascular adverse reactions due to mineralocorticoid excess zytiga may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from cyp17 inhibition see clinical pharmacology 12. Nice rejects janssens zytiga for early, aggressive prostate. Even more men with advanced prostate cancer may benefit from the drug abiraterone zytiga, after the food and drug administration fda expanded the drugs approval on february 7. The additional patent for zytiga us 8,822,438 is listed in the fdas orange book. Fda approves abiraterone acetate in combination with. Zytiga abiraterone acetate is a prescription medicine that is used along with prednisone. European regulators are allowing earlier use of janssens zytiga in the treatment pathway for metastatic prostate cancer. Zytiga abiraterone plus prednisoneprednisolone has been approved to treat newlydiagnosed highrisk metastatic hormonesensitive prostate cancer mhspc in adult men in combination with androgen deprivation therapy adt.
Zytiga was approved by the fda based on 3 clinical studies including more than 3,000 men with metastatic prostate cancerprostate cancer that has spread to other parts of the bodybased on the following measures. Abiraterone acetate, sold under the brand name zytiga among others, is a medication used to. May 23, 2014 back in 2011, zytiga which interferes with testosterone, a prostate cancer cell stimulantwon approval two months ahead of schedule, indicating that the fda wanted it out there as soon as. The development of abiraterone acetate for castrationresistant. Added reason or special circumstance the patient cannot take abiraterone 250mg prior to receiving approval for zytiga 500mg. The healthcare leader was one of the few to show growth in both worldwide pharmaceutical. Common side effects include tiredness, vomiting, headache, joint pain, high bl. Fda expands abiraterone approval for prostate cancer national. The subjects received either zytiga orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg orally twice daily or placebo once daily plus prednisone 5 mg orally twice daily. Use of automated approval and re approval processes varies by program andor therapeutic class.
Jan 18, 2018 twelve generic drugmakers have submitted applications for u. Fda approves yonsa, a new abiraterone acetate formulation. Psa was in normal range for 26 months i think, with only major side effect being hot flashes and some lack of sexual desire, but the severity of hot flashes was cut in half by taking 10mg of. Zytiga, is considered to reflect the clinical activity of abiraterone acetate. Zytiga linked to better quality of life in men with prostate. Fda initially approved abiraterone acetate with prednisone in 2011 for patients with metastatic castrationresistant prostate cancer crpc who. The fda has expanded the approval of abiraterone zytiga to treat men with metastatic prostate cancer. The fda approval of zytiga was based on a randomized, placebocontrolled, multicenter study in 1,195 subjects. Mar 27, 2021 zytiga should not be handled by females who are or may become pregnant see how suppliedstorage and handling 16.
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