Year8
/ ' - < The precursor is a fast-growing cancer in which patients' bone marrow produces too many lymphoblasts, a type of immature white blood cell. The Philadelphia chromosome is an abnormality that sometimes occurs in the bone marrow of people with leukemia. The National Cancer Institute predicts that one million Americans will be diagnosed with the disease and one will die from the disease in 2020.
< B is an immunotherapy drug, which uses part of the body's immune system to fight diseases such as cancer. B is the first drug approved to destroy leukemia cells by working with the body's cells, a type of white blood cell or lymphocyte.
< This drug acts as a connector between proteins and is found on the surface of most cells, lymphoblasts. It is a protein on the cell surface. This drug is used for patients whose cancer has gotten worse after treatment (recurrent) or has not responded to previous treatments (refractory).
< B was approved more than a month earlier than its prescription drug applicant payment target date, which is the date the drug review is scheduled to be completed.
< The safety and efficacy of B were evaluated in a clinical study involving patients with Philadelphia chromosome-negative relapsed or refractory precursors. All patients were treated with B infusions, a method of injecting drugs into the bloodstream, usually using a needle, for at least a few weeks. Results showed that 3 subjects had no evidence of disease (complete remission) for approximately .
< B was approved under the Accelerated Approval Program, which allows approval of a drug to treat a life-threatening disease based on clinical data showing that the drug is effective on a surrogate endpoint that is reasonably likely to predict clinical benefit for patients. disease.
< The program would give patients earlier access to promising new drugs, but companies applying for the drugs would need to conduct confirmatory clinical trials. The manufacturer of B is required to conduct a study to demonstrate that the drug improves survival in subjects with relapsed or refractory Philadelphia chromosome-negative precursors.
< B carries a boxed warning alerting patients and health care professionals that some clinical trial participants experienced hypotension and difficulty breathing during the initial stages of treatment and experienced short-term difficulty thinking (encephalopathy) or other neurological side effects. .
< In patients treated with B, the most common side effects were fever (pyrexia), headache, tissue swelling (peripheral edema), fever due to low white blood cell count (febrile neutropenia), nausea, and hypokalemia (hypokalemia), fatigue, constipation, diarrhea and tremor.
< Approval B was accompanied by a Risk Assessment and Mitigation Strategy (R) that includes a communication plan to inform health care providers of the product's serious risks and the potential for preparedness and management errors. B is marketed by Amgen, Thousand Oaks, California, USA.
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