Tags : (niraparib)

GSK’s Zejula (niraparib) Receives the US FDA’s Approval as 1L

Shots: The approval is based on P-III PRIMA study assessing Zejula (300/200mg, qd) vs PBO in patients with newly diagnosed advanced ovarian cancer following complete or partial response to platinum-based CT regardless of biomarker status The P-III PRIMA study resulted in a 57% improvement in PFS in HRd population and a 38% reduction in the […]Read More

GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib)

Shots: The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process The submission is based on P-III PRIMA study assessing Zejula vs […]Read More

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy

Shots: Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% […]Read More

GSK’s Zejula (niraparib) Receives FDA’s Approval for Late-line Treatment in

Shots: The approval for the expanded indication is based on P-II QUADRA study assessing Zejula (niraparib) in 463 patients relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer prior treated with >3 CT regimen and whose cancer is associated with homologous recombination deficiency (HRD) The P-II QUADRA study results demonstrated ORR (24%) with […]Read More

Janssen’s Niraparib Receives the US FDA’s Breakthrough Therapy Designation for

Shots: The breakthrough designation is based on P-II GALAHAD study assessing Niraparib in adult patients with BRCA1/2 gene-mCRPC and DNA-repair gene defects (DRD) prior treated with androgen-receptor targeting therapies and docetaxel The FDA’s BT designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious […]Read More

GSK Reports Results of Zejula (niraparib) in P-III PRIMA Study

Shots: The P-III PRIMA study involves assessing of Zejula (200 mg, qd) vs PBO as 1L maintenance therapy in patients in a ratio (2:1) with stage III or IV ovarian cancer following platinum-based chemotherapy The P-III PRIMA study resulted in meeting its 1EPs i.e, improvement in PFS in women regardless of their biomarker status, safe […]Read More

Resolution Bioscience Collaborates with Janssen to Develop Cell-Free DNA CDx

Shots: Janssen and Resolution Bioscience develops Resolution’s HRD liquid biopsy test as a companion diagnostic for Janssen’s Niraparib, being investigated for the treatment of metastatic castration-resistant prostate cancer The Resolution HRD assay will allow Janssen to identify patients with prostate cancer who may benefit from Niraparib therapy. In 2016, Janssen got exclusive WW license from […]Read More

Zai Lab Receives Priority Review for Zejula’s (niraparib) NDA from

Shots: The priority review is granted to Zai Lab’s Zejula as a maintenance treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to Pt-based CT in adults The NMPA’s Priority Review is granted to the drugs to accelerate drug’s registration and approval in China […]Read More

GSK to Acquire Tesaro for its Zejula (niraparib) for $5.1B

Shots: GSK to acquire Tesaro, in all stock transaction with its Zejula and preclinical candidates. Tesaro to get $75/share in cash for a premium of 62% with total deal value of $5.1B The focus of acquisition is to build oncology portfolio with Tesaro’s products for targeting multiple cancers including ovarian, lung and prostate cancer. In […]Read More