The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.
Zymeworks is awaiting key regulatory decisions for zanidatamab, with potential EU and China approvals following. Read more ...
An adult patient with pulmonary arterial hypertension (PAH) and metastatic lung adenocarcinoma showed significant clinical ...
Medpage Today on MSN19h
No Benefit for PD-1 Inhibitors in Certain Gastroesophageal Cancers, FDA Panel SaysThe Oncologic Drugs Advisory Committee (ODAC) decided 10-2 with one abstention that PD-1 inhibitors do not have a favorable ...
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in esophageal cancer with PD-L1 ...
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels ...
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in first-line advanced gastric ...
AstraZeneca is extending its work with Immunai through a multiyear collaboration that aims to implement its ...
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors ...
The results showed that in patients with known CLDN18.2 and PD-L1 status, the median progression-free survival (mPFS) reached ...
The FDA's advisory committee is set to evaluate the use of PD-1 inhibitors in gastric cancer patients, focusing on the risks ...
FDA Expert Panel to Consider Limiting Gastric, Esophageal Cancer Immunotherapies to PD-L1 Expressors
The ODAC will weigh risk-benefit analyses from the FDA and sponsors on Keytruda, Opdivo, and Tevimbra when given with chemo in all comers and in PD-L1-positive subgroups.
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