FDA Approves Pembrolizumab/Chemo in Unresectable Pleural Mesothelioma
FDA approves pembrolizumab (Keytruda) plus pemetrexed and platinum-based chemotherapy as first-line therapy for unresectable advanced or metastatic malignant pleural mesothelioma (MPM). The approval is based on KEYNOTE-483 trial data showing improved median overall survival (OS) and progression-free survival (PFS) with the combination therapy compared to chemotherapy alone. The recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks for up to 2 years.
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FDA approves Merck's Keytruda for malignant pleural mesothelioma in combination with chemotherapy, showing improved survival rates in a Phase 3 trial.
FDA approves Keytruda plus pemetrexed and platinum chemotherapy as first-line treatment for inoperable pleural mesothelioma, following Keynote-483 trial results showing survival benefits and similar safety profile to chemotherapy alone.
FDA approved pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy as first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma. KEYNOTE-483 trial showed improved overall survival (17.3 months vs 16.1 months) and objective response rate (52% vs 29%) with pembrolizumab plus chemotherapy. Adverse reactions were consistent with known side effects. Review conducted under Project Orbis, with ongoing reviews at other regulatory agencies.
FDA approves pembrolizumab plus chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial findings showing significant OS improvement.
FDA approves Keytruda plus chemo for unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial showing improved overall survival.
FDA approves Merck's Keytruda for malignant pleural mesothelioma in combination with chemotherapy, improving survival rates in a Phase 3 trial.
FDA approves pembrolizumab (Keytruda) plus pemetrexed and platinum-based chemotherapy as first-line therapy for unresectable advanced or metastatic malignant pleural mesothelioma (MPM). The approval is based on KEYNOTE-483 trial data showing improved median overall survival (OS) and progression-free survival (PFS) with the combination therapy compared to chemotherapy alone. The recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks for up to 2 years.
FDA approves pembrolizumab plus pemetrexed and platinum chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma, based on improved overall and progression-free survival in the KEYNOTE-483 trial.
Merck & Co. received FDA approval for Keytruda in malignant pleural mesothelioma, used with pemetrexed and platinum chemotherapy. The phase 2/3 trial showed a 21% reduction in death risk compared to chemotherapy alone, with median overall survival of 17.3 months.
The FDA approved pembrolizumab plus pemetrexed and platinum-based chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma. KEYNOTE-483 study showed improved overall survival and reduced risk of disease progression with pembrolizumab. Common adverse effects included fatigue and nausea, with higher discontinuation rates in the pembrolizumab arm.
Merck & Co. wins first U.S. approval for Keytruda in malignant pleural mesothelioma, based on Phase 3 study showing improved survival with Keytruda plus chemotherapy.
FDA approves Merck’s Keytruda for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 trial results showing significant survival and progression-free survival benefits.
FDA approves pembrolizumab (Keytruda) plus pemetrexed and platinum chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma. KEYNOTE-483 study showed improved overall survival (OS) and progression-free survival (PFS) with pembrolizumab plus chemotherapy compared to chemotherapy alone. The combination also increased the objective response rate and reduced the risk of disease progression or death. Safety data indicated higher rates of adverse effects in the pembrolizumab arm, with fatigue and nausea being the most common.
FDA approves MSD’s KEYTRUDA with chemotherapy for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM), based on Phase II/III IND.227/KEYNOTE-483 trial results showing significant improvement in overall survival.
The FDA approved Keytruda (pembrolizumab) as a first-line treatment for unresectable malignant pleural mesothelioma, requiring its use with chemotherapy. Keytruda, a PD-L1 immune checkpoint inhibitor, blocks a protein that allows tumors to grow. The approval expands access to Keytruda for all unresectable pleural mesothelioma patients, not just those with high PD-L1 levels. The decision follows the KEYNOTE-483 trial, which showed improved survival and response rates with Keytruda combined with chemotherapy.
FDA approves Merck's Keytruda for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma, based on KEYNOTE-483 study showing improved overall survival and progression-free survival.