Difference between revisions of "Niraparib and abiraterone (Akeega)"
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(Created page with "==Mechanism of action== A fixed dose combination of niraparib and abiraterone. Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes PARP-1 and PARP-2, which are invol...") |
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*2023-08-11: Initial approval with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant [[prostate cancer]] (mCRPC), as determined by an FDA-approved test. ''(Based on MAGNITUDE)'' | *2023-08-11: Initial approval with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant [[prostate cancer]] (mCRPC), as determined by an FDA-approved test. ''(Based on MAGNITUDE)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *2023-04-19: Initial authorisation for treatment of adult patients with [[prostate cancer]]. | ||
==Also known as== | ==Also known as== | ||
| + | *'''Code name:''' CJNJ-67652000 | ||
*'''Brand name:''' Akeega | *'''Brand name:''' Akeega | ||
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[[Category:Oral medications]] | [[Category:Oral medications]] | ||
[[Category:Mutation-specific medications]] | [[Category:Mutation-specific medications]] | ||
| − | [[Category: | + | [[Category:PARP1 inhibitors]] |
| + | [[Category:PARP2 inhibitors]] | ||
[[Category:CYP17 inhibitors]] | [[Category:CYP17 inhibitors]] | ||
[[Category:Prostate cancer medications]] | [[Category:Prostate cancer medications]] | ||
| + | [[Category:EMA approved in 2023]] | ||
[[Category:FDA approved in 2023]] | [[Category:FDA approved in 2023]] | ||
Latest revision as of 13:55, 26 November 2023
Mechanism of action
A fixed dose combination of niraparib and abiraterone. Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes PARP-1 and PARP-2, which are involved in DNA repair. Inhibiting PARP-1 and PARP-2 may result in formation of PARP-DNA complexes, DNA damage, apoptosis, and cell death. PARP proteins utilize base-excision repair (BER) to identify and repair single strand DNA breaks. Abiraterone is an antiandrogen, androgen biosynthesis inhibitor, CYP17 inhibitor. Inhibits the 17 α-hydroxylase/C17,20-lyase (CYP17) enzyme that is required for androgen biosynthesis, leading to a decrease in androgen production in testicular, adrenal, and prostate tumor tissues.
Diseases for which it is established
History of changes in FDA indication
- 2023-08-11: Initial approval with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. (Based on MAGNITUDE)
History of changes in EMA indication
- 2023-04-19: Initial authorisation for treatment of adult patients with prostate cancer.
Also known as
- Code name: CJNJ-67652000
- Brand name: Akeega