An upcoming FDA oncology adcomm meeting will scrutinize GSK's Zejula
2022年9月21日 · Shortly after GSK disclosed (PDF) to physicians that it had "voluntarily withdrawn" one Zejula indication, the FDA has published notice of an advisory committee meeting to review another approved...
Oncologic Drugs Advisory Committee to review Zejula overall …
2022年9月22日 · Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials. GSK is building a robust clinical development programme by assessing activity across multiple tumour types and evaluating several …
GSK Posts Mixed Survival Data for Jemperli/Zejula Combo in
2024年12月20日 · GSK on Friday unveiled headline findings from the Phase III FIRST-ENGOT-OV44 study, posting mixed survival results for add-on Jemperli to standard-of-care chemotherapy and Zejula in patients with advanced ovarian cancer.. The pharma did not reveal specific data in its press release, announcing only that the FIRST trial hit its primary endpoint: Adding Jemperli, an anti-PD-1 antibody, led to ...
GSK hits another oncology hurdle as Zejula use is limited again
5 天之前 · GSK has had another setback in its oncology business, after the FDA asked it to restrict use of its PARP inhibitor Zejula in ovarian, fallopian tube, or primary peritoneal cancer to patients with...
Under FDA pressure, GSK limits use of ovarian cancer drug
2022年11月11日 · GSK will stop selling the drug Zejula for some ovarian cancer patients whose disease is stable after a second line of chemotherapy, the company said Friday, following pressure from the Food and Drug Administration to pull the medicine from the market in …
'Eligibility challenges' derail GSK's Zejula breast cancer trial
2023年4月26日 · In a phase 3 trial of Zejula in certain types of breast cancer, GSK’s bid to track tumor cells at the molecular level has helped patients catch metastatic disease before symptoms set in. While...
GSK's oncology business suffers fresh blow with Zejula setback
2022年11月11日 · Britain's GSK said on Friday it would limit the use of its ovarian cancer drug Zejula in the United States as a second treatment option to keep cancer at bay in patients whose tumours carry...
Zai Lab Presents Interim Overall Survival Data for ZEJULA® …
2022年12月15日 · In March 2022, Zai Lab announced that, in the company’s Phase 3 PRIME study, ZEJULA demonstrated a statistically significant and clinically meaningful improvement in PFS with a tolerable safety profile when given with an individualized starting dose regimen in Chinese patients with newly diagnosed advanced ovarian cancer, regardless of ...
Mixed results for GSK’s Zejula/Jemperli combo
2024年12月20日 · UK pharma major GSK (LSE: GSK) today released mixed headline results from the FIRST-ENGOT-OV44 Phase III trial evaluating Zejula (niraparib) and Jemperli (dostarlimab) in first line advanced ovarian cancer.
Relief for GSK as Tesaro’s Zejula hits the mark in ovarian cancer
2024年12月22日 · In the PRIMA trial, Zejula (niraparib) improved progression-free survival when used as a maintenance therapy in women with ovarian cancer after chemotherapy. Crucially for GSK, the study also...