Mesothelioma

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Data from the phase 2/3 KEYNOTE-483 trial support the CHMP’s recommendation for approving pembrolizumab/chemotherapy in the European Union.
Pembrolizumab/Chemo Earns Positive EU CHMP Opinion in Mesothelioma

November 15th 2024

Data from the phase 2/3 KEYNOTE-483 trial support the CHMP’s recommendation for approving pembrolizumab/chemotherapy in the European Union.

Data from the KEYNOTE-483 trial support the FDA approval of the pembrolizumab-based combination in this pleural mesothelioma population.
FDA Approves Pembrolizumab/Chemo in Unresectable Pleural Mesothelioma

September 17th 2024

Data from the phase 2 NIPU trial support the FDA’s fast track designation for UV1 in combination with nivolumab and ipilimumab as a treatment for those with unresectable pleural malignant mesothelioma.
FDA Grants Fast Track Designation to UV1 Vaccine Combo in Unresectable Mesothelioma

February 6th 2024

The accepted new drug application is for Pemrydi RTU, a ready-to-use injectable that requires no reconstitution, dilution, or refrigeration.
FDA Accepts NDA for Pemetrexed Injection in NSCLC, Mesothelioma

June 16th 2023

SynKIR-110, which received fast track designation from the FDA, is currently under investigation as treatment for patients with mesothelioma in the phase 1 STAR-101 trial.
FDA Grants Fast Track Designation to Novel T-Cell Therapy in Mesothelioma

April 10th 2023

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