Fda s Recent Approvals Of Pd 1 Pathway Drug Treatments

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 re ceived 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 completeShow MoreRelatedTreatment Of Metastatic Squamous Non Small Cell Lung Cancer1744 Words   |  7 PagesSquibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015 WEDNESDAY, March 4, 2015 (HealthDay News) -- U.S. Food and Drug Administration approval of Opdivo (nivolumab) has been expanded to include advanced non-small cell lung cancer (NSCLC), the agency said Wednesday in a news release. Lung cancer is the leading cause of cancer death in the United States, having been diagnosed more than 224,000 times and causing more than 159,000 deaths in 2014, the FDA said. NSCLCRead MoreRole Of Cancer As A Genetic Disease2893 Words   |  12 PagesCase Study: BIOT 635 Prahelika Reddy ROLE OF ONCOGENES IN CANCER RESEARCH 1. Introduction The idea that development of cancer as a genetic disease was first postulated by Cavenee et al and developed by Fearon and Vogelstein. According to COSMIC (Catalogue of Somatic Mutations in Cancer) database, the current list of known somatic genetic mutations leading to cancer is 522. Genes which undergo mutations leading to cancer can be classified into two groups - Proto-Oncogenes and Tumor Suppressor genesRead MoreAn Evaluation of an on-Farm Food Safety Program for Ontario Greenhouse Vegetable Producers; a Global Blueprint for Fruit and Vegetable Producers51659 Words   |  207 Pagestrends was developed through the examination of current on-farm food safety issues and programs, with specific focus on the Ontario Greenhouse Vegetable Growers (OGVG) hazard analysis critical control point (HACCP)- based initiative. In 2003, OGVG s 200 members had a combined farm-gate value of $350 million and represented 41 per cent of North American greenhouse vegetable production. Program implem entation barriers identified included: perceived costs of participation, the priority of food safetyRead MoreProject Mgmt296381 Words   |  1186 PagesCross Reference of Project Management Body of Knowledge (PMBOK) Concepts to Text Topics Chapter 1 Modern Project Management Chapter 8 Scheduling resources and cost 1.2 Project defined 1.3 Project management defined 1.4 Projects and programs (.2) 2.1 The project life cycle (.2.3) App. G.1 The project manager App. G.7 Political and social environments F.1 Integration of project management processes [3.1] 6.5.2 Setting a schedule baseline [8.1.4] 6.5.3.1 Setting a resource schedule 6.5.2.4 Resource