Fda approves expanded zytiga indication for treatment. Abiraterone acetate is a prodrug that is converted in vivo to abiraterone. Fda backs prostate cancer drug zytiga for earlier use cbs news. Food and drug administration fda has approved zytiga abiraterone acetate, an oral, oncedaily medication for. In the early 1990s, mike jarman, elaine barrie, and gerry potter of the. Fda initially approved abiraterone acetate with prednisone in 2011 for. Big pharmas market access mission deloitte united states. Zytiga abiraterone acetate tablets for oral administration initial u. Development history and fda approval process for zytiga. Added initial approval period of 3 months and kept 6 months for continued approval period. Richard pazdur said the fda s approval provides patients and health care providers the option of using zytiga earlier in the course of treatment.
Zytiga is used to treat men with prostate cancer that has spread to other parts of the body. Zytiga abiraterone acetate plus prednisone approved for. Zytiga prolonged the lives of men with latestage prostate cancer who had received prior treatments and had few available therapeutic options, said richard pazdur, m. Zytiga abiraterone acetate receives fda approval for. Horsham, pa april 28, 2011 centocor ortho biotech inc. Abiraterone acetate zytiga, janssen biotech is a new cytochrome p450 cyp 17 inhibitor that was approved by the fda in 2011 in combination with prednisone for crpc in patients who have received prior docetaxel chemotherapy.
Prior authorization approval criteria fallon health. The food and drug administration fda has updated the label for zytiga abiraterone acetate plus prednisone to include data from the final analysis of the phase 3 couaa302 study, which detailed a significant prolongation in overall survival os for zytiga versus placebo in chemotherapynaive men with metastatic castrationresistant prostate cancer mcrpc. 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. Abiraterone has received food and drug administration fda 28 april 2011. Specifically it is used together with corticosteroid for. Use with caution in patients with a history of cardiovascular disease or with.
Abiraterone acetate zytiga, janssen biotech is a new cytochrome p450 cyp. In latitude a randomized placebocontrolled, multicenter clinical trial, which used prednisone 5 mg daily in combination with mg abiraterone acetate daily, grades 34. 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. Abiraterone acetate zytiga, janssen biotech is a new cytochrome p450 cyp 17 inhibitor that was approved by the fda in 2011 in combination with prednisone for crpc in patients who have received.
Do not start or stop other medicines without talking to your healthcare provider. Abiraterone acetate has received fda 28 april 2011, ema 23 september. Fda approval for abiraterone for treatment of metastatic. The generic ingredient in zytiga is abiraterone acetate. The approval was based on findings from a phase ii study comparing the yonsa formulation of abiraterone acetate to the original, zytiga, which was approved in 2011. Policy history date action 12014 implementation of step policy. Bach, md, mapp, limits on medicares ability to control rising spending on cancer drugs. This study is created by ehealthme based on reports of 16,9 people who have side effects when taking zytiga from the food and drug administration fda. Regarding food effects on abiraterone, food increased exposure of abiraterone, where this increased exposure posed a risk for the adverse event of increased qtc interval. Some good morning news, zytiga approved by the fda for. Abiraterone zytiga, a novel agent for the management of. Ecog ps score of 1 and 45% had a history of bone and softtissue metastases. The fda has approved the expanded use of abiraterone acetate zytiga to firstline therapy for mcrpc. Which patents cover zytiga, and what generic alternatives are available.
Zytiga abiraterone acetate is a prescription medicine that is used along with prednisone. Approved drug products with therapeutic equivalence evaluations orange book short description. Abiraterone acetate is approved by the fda as an oral treatment option for crpc. It is not known if zytiga is safe and effective in females or children. May 16, 2020 which patents cover zytiga, and what generic alternatives are available. Products approved prior to the january 1, 1982 contain the phrase. Zytiga abiraterone acetate is a cyp17 inhibitor indicated for the treatment of patients with metastatic castrationresistant prostate cancer and metastatic highrisk castrationsensitive prostate cancer. Article nice set to deny access to ukdiscovered prostate cancer. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for zytiga abiraterone. It was approved for the treatment of mcrpc in 2011 and was subsequently. Janssen submits supplemental new drug application to u.
February 3, 2012 office action excerpt from prosecution history of 438 patent. Prostate cancer that has metastasized spread to other parts of the body. Abiraterone acetate is approved to be used with prednisone to treat. A statistically significant os benefit in favour of the zytigatreated group was demonstrated with a 19. Abiraterone, also known as abiraterone acetate and sold under the brand name zytiga among others, is a medication used to treat prostate cancer. More than 330,000 patients worldwide, including 1,000. Epidiolex may affect the way other medicines work, and other medicines may affect how epidiolex works. Persons with disabilities having problems accessing the pdf files below may call.
Zytiga approved in the eu for use in the treatment of. New abiraterone acetate formulation approved by fda for mcrpc. Food and drug administration fda has approved a generic version of zytiga, the new drugs name is yonsa. Food and drug administration fda has approved a broader indication for the oral, oncedaily medication zytiga. Dec 25, 2019 zytiga pharmacokinetics absorption bioavailability. May 07, 2020 in latitude a randomized placebocontrolled, multicenter clinical trial, which used prednisone 5 mg daily in combination with mg abiraterone acetate daily, grades 34 hypokalemia were detected in 10% of patients on the zytiga arm and 1% of patients on the placebo arm, grades 34 hypertension were observed in 20% of patients on the. No treatment prolonged overall survival os in patients with metastatic castrationresistant prostate cancer mcrpc until docetaxel combined with prednisone received food and drug administration fda approval in 2004. Zytiga prolonged the lives of men with latestage prostate cancer who had received prior treatments and had few available. This fda announcement is an expansion of their prior approved april 2011 for the use of zytiga to treat men with latestage metastatic castrationresistant advanced prostate cancer after treatment. This fda approval represents a welcome new option in the treatment of metastatic prostate cancer, howard scher, md, chief of the genitourinary oncology service, sidney kimmel center for urologic and prostate cancers at memorial sloankettering cancer center, who was one of the colead investigators for the phase iii study, said in a news release.
Fda approval history for zytiga abiraterone used to treat prostate cancer. Use zytiga with caution in patients with a history of cardiovascular disease. Fda approves zytiga label update for use in chemonaive men. About zytiga 8 since its approval in 2011, zytiga has been approved in more than 60 countries worldwide, many thousands of men have received treatment with it, and it is quickly becoming one of the cornerstones of our oncology offerings. A generic version of zytiga has been approved by the fda. Criteria for approval bullet points below are all inclusive unless otherwise noted. Fda expands abiraterone approval for prostate cancer national. It is a novel formulation of abiraterone acetate that needs to be used in combination with methylprednisolone for the treatment of men with metastatic castrationresistant prostate cancer mcrpc. According to representatives from janssen research. Call your healthcare provider for medical advice about side effects.
Prescription treatment with zytiga abiraterone acetate. The food and drug administration fda has just announced that they have approved zytiga abiraterone acetate for use prior to chemotherapy. No treatment prolonged overall survival os in patients. In combination with prednisone for the treatment of patients with. This fda announcement is an expansion of their prior. Jan 16, 2020 a statistically significant os benefit in favour of the zytiga treated group was demonstrated with a 19. In patients whose disease is castration resistant has not responded to treatments that lower testosterone levels. A fda approval for zytiga before chemotherapy on the horizon. It is also being studied in patients with earlierstage prostate cancer and in women with metastatic breast cancer. Zytiga 500 mg filmcoated tablets summary of product.
This drug has thirtyfive patent family members in nineteen countries. Zytiga abiraterone acetate product information pdf. Zytiga is being approved ahead of the products june 20, 2011 regulatory goal date. Abiraterone was described in 1995, and approved for medical use in the united states and europe.
Zytiga is a drug marketed by janssen biotech and is included in one nda. Fda label information for this drug is available at dailymed. Zytiga pharmacokinetics absorption bioavailability. Zytiga is additionally approved for the treatment of men with. Approval 2011 recent major changes indications and usage 1 122012 dosage and administration, dose modification guidelines 2. Monthly and median costs of cancer drugs at the time of approval by the fda, 19652008 graphic. The food and drug administration fda has updated the label for zytiga abiraterone acetate plus prednisone to include data from the final analysis of the phase 3 couaa302 study, which detailed a.
This fda approval represents a welcome new option in the treatment of metastatic prostate cancer, howard scher, md, chief of the genitourinary oncology service, sidney kimmel center for urologic and. Prostate cancer is the most common malignancy in men, with an estimated 29,480 deaths in the united states in 2014. There is one patent protecting this drug and two paragraph iv challenges. See 17 for patient counseling information and fdaapproved patient labeling. The drug, which decreases testosterone production, was approved in april 2011 as a secondline treatment after docetaxel chemotherapy in the same population. Fda approves abiraterone acetate in combination with prednisone. Richard pazdur said the fdas approval provides patients and health care providers the option of using zytiga earlier in the course of treatment. The fda has expanded the approval of abiraterone zytiga to treat men with metastatic prostate cancer. Abiraterone, also known as abiraterone acetate and sold under the brand name zytiga among. The date the product was approved as stated in the fda approval letter to the applicant. Added initial approval period of 3 months and kept 6 months for continued approval. Specifically it is used together with corticosteroid for metastatic castrationresistant prostate cancer mcrpc and metastatic highrisk castrationsensitive prostate cancer mcspc. Approved drug products with therapeutic equivalence evaluations orange book is only listed in. Zytiga abiraterone acetate tablets for oral use initial u.
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