FDA Grants Jemperli Breakthrough Therapy Designation in …
22 hours ago · Jemperli received breakthrough therapy designation by the FDA for locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer. ... according to the news release. Regarding safety, the safety and tolerability profile of the agent was also noted to be generally consistent with the known safety profile of the agent and ...
GSK Posts Mixed Survival Data for Jemperli/Zejula Combo in
2 days ago · 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's cancer drug combo meets main goal in ovarian cancer trial
2 days ago · GSK said on Friday that adding its cancer drug Jemperli to both standard-of-care chemotherapy and Zejula as a maintenance therapy improved survival in patients with advanced ovarian cancer without ...
GSK blows Jemperli marching horn against Keytruda with new …
Aug 1, 2024 · On Thursday, the FDA expanded the endometrial cancer use for GSK’s Jemperli, used in combination with chemotherapy, to include patients with mismatch repair proficient (pMMR) or...
Jemperli (dostarlimab-gxly) receives US FDA Breakthrough …
6 days ago · Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development program. ... Keep up to date with our news and recent announcements. GSK. This is …
GSK announces FDA granted BTD for Jemperli | Nasdaq
6 days ago · GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for Jemperli for the treatment of patients with locally advanced mismatch ...
Jemperli Cancer Drug: What To Know As GSK Says It Improves ... - Forbes
Mar 16, 2024 · Jemperli, a cancer drug manufactured by GlaxoSmithKline, improved survival for patients diagnosed with a form of uterine cancer by more than one year, the British drugmaker said Saturday, the...
US FDA expands Jemperli (dostarlimab) plus chemotherapy approval ... - GSK
Aug 1, 2024 · GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer.
US FDA expands Jemperli (dostarlimab-gxly) plus chemotherapy …
PHILADELPHIA, August 01, 2024 -- (BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with...
FDA approves dostarlimab-gxly with chemotherapy for …
On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary...
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