FDA has approved pembrolizumab marketed as Keytruda by Merck in combination with pemetrexed and platinum chemotherapy as a first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
The approval of pembrolizumab + chemotherapy was based on data from the KEYNOTE-483 trial, offering hope for MPM patients without prior systemic therapy.
This review of pembrolizumab for MPM was conducted under Project Orbis, a collaborative initiative of the FDA’s Oncology Center of Excellence.
The FDA employed several programs to expedite the review of the pembrolizumab application, including the Assessment Aid.
Additionally, the application received priority review status, signifying its potential to improve the treatment of MPM significantly.
Healthcare professionals were encouraged to report to the FDA’s MedWatch Reporting System all serious adverse events suspected to be associated with pembrolizumab in MPM patients.
Source: FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-unresectable-advanced-or-metastatic-malignant-pleural
