The Phase 1 study, a non-randomised, open-label, multicentre trial, is evaluating IKS014 in patients with locally advanced or metastatic solid tumours expressing HER2
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
Results support the development of tislelizumab in potentially synergistic combinations across Novartis advanced therapeutic platforms for the treatment of an array of solid tumours
The medicine is now approved for eight indications across five different types of cancer in China.
The FDA approval makes PD-L1 IHC 22C3 pharmDx the only companion diagnostic approved to detect tumors expressing PD-L1 in esophageal or GEJ carcinoma patients for KEYTRUDA treatmen
AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
The study will run across 18 sites and enroll roughly 200 patients over 24 months
The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38
Singlera and Pure Medical will team up with local universities, hospital networks, and national healthcare systems across Western Europe for research studies
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