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Fda 's Recent Approvals Of Pd 1 Pathway Drug Treatments

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Section A: FDA’s recent approvals of PD-1 Pathway drug treatments The mechanisms observed from various preliminary studies have led researchers to determine that antibody mediated blockade of the PD-1/PD-L1 pathway should have positive effects on tumor regression. This has led to the development of various drugs to target the PD-1/PD-L1 pathway. In the last decade, checkpoint inhibitory drugs have been utilized to increase cancer survival rates by blocking the PD-1--PD-L1 pathway interactions . By blocking this pathway, various immune cells such as CTLs, NK, and DCs can properly detect cancer cells and trigger T-cell activation thus enabling tumor cell apoptosis. Numerous PD-1 inhibitors have recently been developed as therapeutic…show more content…
Several studies have been conducted showing the effectiveness of the drug in Advanced-Merkel Cell Carcinoma and non-small cell cancer. In a study by Nghiem, a total of 26 patients with advanced Merkel-cell carcinoma received a first line therapy with Pembrolizumab . All had either recurrent locoregional Merkel-cell carcinoma or distant metastatic cancer that were not receptive to surgery or radiation therapy. (45). No patients had previous received systemic therapy, however one patient had received adjuvant chemotherapy more than 6 months before the beginning of the study. Pembrolizumab was administered intravenously at a dose of 2 mg per kilogram of body weight every 3 weeks. Patients were evaluated every 4 weeks to assess progression. Treatment was continued for a maximum of 2 years. Following the study, the overall response rate was 56%, with complete and or partial responses occurring in 14 out of the 25 patients treated. (45).
Similar results were seen in a study that evaluated the maximum tolerated dose, antitumor activity, and pharmokinetics of Pembrolizumab in patients with melanoma and Merkel cell carcinoma. (46). A total of 30 out of 32 patients recruited received Pembrolizumab in various doses (1mg, 2mg, 3mg, and 10mg/kg respectively) intravenously every 2 weeks until tumor progression or toxicity occurred. They found no dose-limiting toxicities occurred and observed that two patients had complete
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