A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma
Latest Information Update: 31 May 2024
At a glance
- Drugs Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Pemetrexed
- Indications Malignant-mesothelioma
- Focus Registrational; Therapeutic Use
- Acronyms KEYNOTE 483
- 29 May 2024 According to a Merck Sharp & Dohme media release, based on data from this trial the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 25, 2024.
- 12 Jan 2024 Planned End Date changed from 31 Dec 2023 to 30 Jun 2024.
- 07 Nov 2023 Results assessing whether the addition of pembrolizumab to platinum pemetrexed would improve overall survival in patients with pleural mesothelioma, published in the Lancet