Tags : Zejula

Regulatory

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment

Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are […]Read More

Pharma

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

Regulatory

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

Regulatory

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

M&A

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