The Oncologic Drugs Advisory Committee (ODAC) decided 10-2 with one abstention that PD-1 inhibitors do not have a favorable ...
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.  | The days of broad stomach cancer labels ...
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 ...
The FDA's advisory committee is set to evaluate the use of PD-1 inhibitors in gastric cancer patients, focusing on the risks ...
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in esophageal cancer with PD-L1 ...
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed ...
Head-to-Head Phase 3 Trial Compared to Pembrolizumab Initiated HONG KONG, Sept. 15, 2024 /PRNewswire/ — At the 2024 European ...
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 ...
Missak Haigentz, MD, highlights some of the significant unmet needs for patients with small cell lung cancer.
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 ...
The results showed that in patients with known CLDN18.2 and PD-L1 status, the median progression-free survival (mPFS) reached ...