The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels ...
Zymeworks is awaiting key regulatory decisions for zanidatamab, with potential EU and China approvals following. Read more ...
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 ...
The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed ...
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in esophageal cancer with PD-L1 ...
"If patients with low or no PD-L1 expression are not expected to benefit based on the available data, then administering anti ...
Missak Haigentz, MD, highlights some of the significant unmet needs for patients with small cell lung cancer.
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 ...
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 ...
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