The USFDA has approved moxetumomab pasudotox injection for the treatment adult patients with relapsed or refractory hairy cell leukemia (HCL). The chemotherapeutic has received orphan product designation which in-turn will provide incentives to developers for innovation of drug intended to treat a rare disease. HCL is a form of chronic lymphocytic leukemia and is named so, as under the microscope they seem to have fine projections on their surface that make them look "hairy". Moxetumomab pasudotox is a conjugated monoclonal antibody, which works by delivering a toxic substance directly to the cancer cells, limiting its effects on healthy cells.
This drug is first of its kind to get approval from FDA for the treatment of HCL. FDA evaluated the drug through its fast track and priority review programs. FDA’s approval was based on a clinical trial which recruited 80 participants having HCL.…
