Targeted Oncology22h
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 ...
MedPage Today1h
No Benefit for PD-1 Inhibitors in Certain Gastroesophageal Cancers, FDA Panel Says
By way of two resoundingly consistent votes, members of an FDA advisory committee agreed that PD-1 inhibitors do not have a favorable risk/benefit profile for gastroesophageal cancers with low PD-L1 ...
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 ...
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 ...
Zymeworks Approaching A Moment Of Truth With Zanidatamab
Zymeworks is awaiting key regulatory decisions for zanidatamab, with potential EU and China approvals following. Read more ...
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 ...
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 ...
MedPage Today2d
Immunotherapy May Not Benefit All Gastroesophageal Cancer Patients, FDA Staff Says
"If patients with low or no PD-L1 expression are not expected to benefit based on the available data, then administering anti ...
J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers
New data show Talvey’s potential in multiple myeloma drug combinations. Elsewhere, AbbVie got more positive Parkinson’s drug ...
Bristol, Merck checkpoint inhibitors focus of FDA advisory committee meeting
An FDA advisory panel on Bristol Myers Squibb Opdivo and Merck Keytruda will examine if PD-L1 tumor expression should limit ...
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 ...
BioPharma Dive1d
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 ...