Related Experiment Videos
Pemetrexed in malignant pleural mesothelioma
Maitreyee Hazarika1, Robert M White, Brian P Booth
1Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA. HazarikaM@cder.fda.gov
Summary
Pemetrexed combined with cisplatin demonstrated improved survival for malignant pleural mesothelioma (MPM) patients, leading to FDA approval. This combination therapy requires folic acid, vitamin B12, and corticosteroids to manage toxicities.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Malignant pleural mesothelioma (MPM) is a rare and aggressive cancer.
- Treatment options for unresectable MPM have historically been limited.
Purpose of the Study:
- To describe the data and analysis supporting the FDA approval of pemetrexed (Alimta) for MPM treatment.
- To review the efficacy and safety data of pemetrexed in combination with cisplatin.
Main Methods:
- A randomized, single-blind, multicenter international trial compared pemetrexed plus cisplatin to cisplatin alone in 448 patients with unresectable MPM.
- Preclinical pharmacology and chemistry data were also assessed.
Main Results:
- Median survival was 12.1 months for pemetrexed-cisplatin versus 9.3 months for cisplatin alone (P=0.021).
- The most common toxicity was myelosuppression (neutropenia); other adverse events included fatigue, nausea, and anemia.
- FDA approval was based on demonstrated survival improvement.
Conclusions:
- Pemetrexed plus cisplatin was approved by the FDA on February 4, 2004, for unresectable MPM.
- Recommended dosage and supportive care (folic acid, vitamin B12, corticosteroids) were established to mitigate toxicity.
- Pemetrexed offers a survival benefit for patients with malignant pleural mesothelioma.