Ofatumumab (OFA) is a fully human type I anti-CD20 IgG1kappa mAb [15,32-37]. Ofatumumab binds to both the small and large extracellular loops (ECL) of CD20 molecule, and is more effective than rituximab at killing target cells. It has been shown to be more potent than RTX against both RTX- sensitive and resistant cells [38]. Its activity against RTX-resistant cells and the potent CDC effect are believed to be due to the proximal epitope of the small loop of CD20 molecule and the high capacity for C1q activation.
OFA (arzerra) has been approved for treatment of relapsed or refractory CLL who have failed fludarabine and alemtuzumab (FA-ref) [39]. OFA is given IV weekly on a fixed dose, 300 mg for dose 1, and 2000 mg weekly x 7 in subsequent doses. This is followed by every four

weeks for 4 more doses [36]. In FA-ref CLL patients, the response rate was 58%. OFA was also studied in 116 patients with RTX-refractory follicular lymphoma (FL) [40]. These patients received 8 weekly infusions (dose 1, 300 mg and doses 2-8, 500 or 1000 mg). The median age was 61 years, and the median number of prior therapies was 4. The overall response rate (ORR) was 13% and 10% for the 500-mg and 1000-mg arms, respectively (Table 1). The median PFS was 5.8 months. Infections, rash, urticaria, fatigue, and pruritus were the most common adverse events. Severe adverse events included neutropenia, anemia, and thrombocytopenia in a subset of patients.
http://www.jhoonline.org/content/pdf/1756-8722-5-64.pdf
OFA (arzerra) has been approved for treatment of relapsed or refractory CLL who have failed fludarabine and alemtuzumab (FA-ref) [39]. OFA is given IV weekly on a fixed dose, 300 mg for dose 1, and 2000 mg weekly x 7 in subsequent doses. This is followed by every four

weeks for 4 more doses [36]. In FA-ref CLL patients, the response rate was 58%. OFA was also studied in 116 patients with RTX-refractory follicular lymphoma (FL) [40]. These patients received 8 weekly infusions (dose 1, 300 mg and doses 2-8, 500 or 1000 mg). The median age was 61 years, and the median number of prior therapies was 4. The overall response rate (ORR) was 13% and 10% for the 500-mg and 1000-mg arms, respectively (Table 1). The median PFS was 5.8 months. Infections, rash, urticaria, fatigue, and pruritus were the most common adverse events. Severe adverse events included neutropenia, anemia, and thrombocytopenia in a subset of patients.
http://www.jhoonline.org/content/pdf/1756-8722-5-64.pdf
16/10 2012 14:25 Camel 0
61529 Jeg tror sgu de har fået solgt fabriken,det er kun en mave fornemelse.
