Tags : Advanced Ovarian Cancer

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

Regulatory

AstraZeneca and MSD’s Lynparza (Olaparib) Receives the CHMP’s Positive Opinion

Shots: The CHMP has recommended the approval of Lynparza + bevacizumab for the 1L maintenance treatment of patients with HRD+ advanced ovarian cancer. The positive opinion is based on a biomarker subgroup analysis of P-III PAOLA-1 study The P-III PAOLA-1 study involves assessing of Lynparza + bevacizumab vs bevacizumab as monothx. for newly diagnosed advanced FIGO […]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

Pharma

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