The drug concentrates in the tumour relative to plasma and brings around 90% durable inhibition of PARP 1 / 2 and a persistent anti-tumour effect.The drug is available in a 100mg-dosed capsule for oral administration.FDA approval for Zejula comes from results of phase III clinical trial known as ENGOT-OV16 / NOVA, a double-blind, placebo-controlled, international clinical study enrolling 553 patients with recurrent ovarian cancer.Patients were enrolled into two independent cohorts based on germline BRCA mutation status. "Given these results, prospective biomarker testing could enable healthcare professionals to personalize therapy for patients with metastatic castration-resistant prostate cancer in the future," Yu said. Zejula, which is also known as niraparib, is already in use as an anti-cancer drug for treating ovarian cancer… J&J is already marketing a follow-up to Zytiga in prostate cancer, Erleada, but that drug is also in a tough spot competition-wise. The median PFS for patients treated with Zejula was 21.0 months, compared to 5.5 months for the control arm.The study also showed that the drug was statistically significant in the treatment of patients in the non-germline BRCA mutant cohort. It does not provide medical advice, diagnosis or treatment. exclude terms.J&J reported a response rate of 41% among prostate cancer patients with BRCA mutations who were treated with Zejula in a clinical trial. The ongoing clinical development programme on the drug includes a phase III clinical trial known as PRIMA, initiated for the evaluation of patients who have received first-line treatment for ovarian cancer.Tesaro has also been conducting several combination studies such as TOPACIO involving Zejula plus pembrolizumab and AVANOVA with the combination of Zejula and bevacizumab.Approval of additional indication comes from the QUADRA study, a phase 2, multi-centre, open-label and single-arm clinical trial.QUADRA is the most extensive clinical study for anti-PARP drugs in women who received more than three treatments for advanced ovarian cancer.A total of 463 patients were enrolled, including women with BRCA+ platinum-sensitive, resistant and refractory disease and women with HRD+ platinum-sensitive disease.Patients were selected based on FDA-approved Myriad myChoice companion diagnostic test.The patients were administered a dose of 300mg once daily; treatment continued until the disease progressed.An objective response rate (ORR) of 24% and a median duration of response (mDOR) of 8.3 months were observed in the FDA-indicated patient population. During the conference, AZ and Merck presented data from a phase 3 trial showing that Lynparza cut the risk of disease progression or death by 66% in patients with BRCA1, BRCA2 or ATM mutations.Roy Baynes, M.D., Merck’s SVP and head of global clinical development, called the Lynparza results “a game-changer” in an interview with FiercePharma, adding that the drug “could easily become a new standard of care” in prostate cancer patients with the mutations.The Lynparza trial compared men treated with the drug to those who received Johnson & Johnson’s Zytiga or Pfizer and Astellas’ Xtandi. Patients taking Lynparza did not see their disease worsen for a median time of 7.4 months vs. 3.6 months for the other drugs.J&J is already marketing a follow-up to Zytiga in prostate cancer, Erleada, but that drug is also in a tough spot competition-wise. The oral ovarian cancer treatment Zejula has been given Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who carry BRCA mutations and have been previously treated with certain therapies, namely taxane chemotherapy and androgen-receptor targeted therapy.
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