HEALTH NEWS: APPROVAL OF ZEJULA (NIRAPARIB)
Niraparib was approved by the FDA yesterday after being granted fast track status at the end of last year. I have been watching this drug since the NOVA study was published in the NEJM last year and it is a groundbreaking treatment choice
or women in this category.
•Niraparib, which will be marketed under the brand name Zejula, is the first poly ADP-ribose polymerase (PARP) inhibitor approved and is for the treatment of patients with platinum-sensitive ovarian cancer, fallopian tube, or primary peritoneal cancer.
•Niraparib has demonstrated a clinically meaningful progression free survival in women with recurrent ovarian cancer regardless of BRCA mutation.
•This is a broader indication than its AstraZeneca rival, Lynparza which is for BRCA mutation patients only.
•The most common side effects in the NOVA trial were thrombocytopenia, anemia, neutropenia, and hypertension.
•Approximately 22,000 women in the U.S. are diagnosed with ovarian cancer each year and it is the fifth most frequent cause of cancer death among women.
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