Tags : Advanced Ovarian Cancer

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

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

Merck KGaA and Pfizer Terminates P-III JAVELIN Ovarian PARP 100

Shots: The termination is based on P-III JAVELIN Ovarian PARP 100 study (B9991030) results assessing Bavencio (avelumab) + CT followed by avelumab + Talzenna (talazoparib) vs PBO in 9,000 patients with locally advanced or metastatic ovarian cancer The termination is due to its third failure with unmet degree of benefit observed with avelumab in ovarian […]Read More