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FDA Approves Pembrolizumab IV Injection as First-Line Immunotherapy for MSI-H/dMMR Metastatic CRC
On June 29, 2020, the FDA approved pembrolizumab (Keytruda; Merck) as an intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer (CRC).
The application for this approval—which marks the first immunotherapy sanctioned for first-line use in this patient population, and the first that can be administered to patients not simultaneously receiving chemotherapy—was granted Priority Review.
“Metastatic [CRC] is a serious and life-threatening disease with a poor prognosis. Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence, in a press statement released by the organization.
“Having a non-chemotherapy option available for selected patients is a noteworthy paradigm shift in treatment,” he continued.
This approval was based on findings from an open-label, multi-center, active-controlled trial in which pembrolizumab was compared with chemotherapy in 307 patients with MSI-H or dMMR metastatic CRC.
A statistically significant improvement in progression-free survival (PFS) was reported via blinded independent review, and the median PFS was 16.5 months with pembrolizumab versus 8.2 months with chemotherapy.
Fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain are the side effects most frequently reported with pembrolizumab. The treatment can also cause immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.—Hina M. Porcelli
Source: US Food and Drug Administration. FDA approves first-line immunotherapy for patients with MSI-H/dMMR metastatic colorectal cancer. June 29, 2020. www.fda.gov/news-events/press-announcements/fda-approves-first-line-immunotherapy-patients-msi-hdmmr-metastatic-colorectal-cancer. Accessed June 29, 2020.
