Medpage Today on MSN19h
No Benefit for PD-1 Inhibitors in Certain Gastroesophageal Cancers, FDA Panel Says
The Oncologic Drugs Advisory Committee (ODAC) decided 10-2 with one abstention that PD-1 inhibitors do not have a favorable ...
FiercePharma1d
UPDATED: Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal cancers
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.  | The days of broad stomach cancer labels ...
precisionmedicineonline3h
FDA Panel Finds Limited Immunotherapy Benefit in PD-L1-Negative Gastric, Esophageal Cancer
The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.
FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients
The FDA's advisory committee is set to evaluate the use of PD-1 inhibitors in gastric cancer patients, focusing on the risks ...
Medpage Today on MSN3d
Immunotherapy May Not Benefit All Gastroesophageal Cancer Patients, FDA Staff Says
An FDA advisory committee will consider whether PD-L1 expression cutoffs should guide use of checkpoint inhibitors to treat ...
BioSpace2d
FDA Considers Narrowing Label of PD-1 Drugs in Stomach Cancer Ahead of Adcomm Meeting
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed ...
Targeted Oncology1d
FDA ODAC Finds Limited Benefit for Checkpoint Inhibitors in Low PD-L1 Gastric Cancer
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in first-line advanced gastric ...
Targeted Oncology1d
FDA ODAC Votes Against Checkpoint Inhibitors in PD–L1-Negative Esophageal Cancer
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in esophageal cancer with PD-L1 ...
FiercePharma3d
Ahead of adcomm, FDA challenges broad use of PD-1 drugs in stomach cancer patients
Besides stomach cancer, the FDA also raised a similar concern for PD-1 drugs in first-line esophageal squamous cell carcinoma ...
BioPharma Dive2d
Transcenta Updates Encouraging Efficacy Data from First-line Triple Combo Trial of Osemitamab for G/GEJ Cancer
The results showed that in patients with known CLDN18.2 and PD-L1 status, the median progression-free survival (mPFS) reached ...
Cure Today14d
Imfinzi After Primary Treatment Does Not Improve Disease-Free Survival in PD-L1-Positive NSCLC
Patients with NSCLC did not see a disease-free survival benefit with Imfinzi after surgery compared with taking a placebo.
Becker's Hospital Review2d
FDA challenges broad use of PD-1 inhibitors in stomach cancer patients
The FDA is reassessing the approval of immune checkpoint inhibitors for treating advanced HER2-negative gastric adenocarcinoma, questioning their broad application regardless of patients' PD-L1 ...