The FDA has cleared a new Drug for treating B-Cell Leukemia. This drug, dubbed Besponsa, has been developed by Pfizer Inc. and is useful against a very rare form of the cancer form also known as relapsed or refractory B-Cell precursor acute lymphoblastic leukemia, or ALL. The certification though comes with a boxed warning.

Who is this drug targeted at?

The Besponsa is made for adults who suffer from B-Cell ALL. These people may have found some benefit from initial treatment or may not have, but in all of these cases, the chances of death are high. There are no medications for these people, which can alleviate their problems and give them a chance at surviving.

The new drug will look to achieve this by remedying the issues in the patients’ bodies.

The B-Cell ALL cancer is a particularly dangerous form of the disease in which the B-Cell lymphocytes of those affected are produced at a faster rate. This production of too many B-Cells lymphocytes, which are nothing but immature white blood cells, causes the cancer to form and cause complications in the body. The National Cancer Institute predicts that nearly 5,970 people in the United States will be diagnosed with this disease in the coming year, out of which almost 1,440 people will die.

The new drug has been proven to be effective in such cases. The Besponsa, when ingested, goes inside the body and binds itself to the B-Cell lymphocytes. This stops the production of the cancer cells, thus effectively decreasing cancer affliction.

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How were the clinical trials carried out?

The testing of the drug was performed on 326 people suffering from B-Cell ALL. All of these participants had already received one or two prior treatments for the disease. Random patients were selected among these to be treated with Besponsa, while the rest were treated with a chemotherapy regimen. The drugs were administered to 218 patients and out of these 35.8 percent of the people showed complete remission of the disease for an average of 8.0 months.

Out of the people who received alternate chemotherapy only around 17.4 percent of the patients experienced complete remission of the cancer and that too on an average of 4.9 months. However, side effects of the drug include the possibility of low platelet counts, anemia, fever, hemorrhage, headache, and nausea. The box of the medication also comes with a warning that reads that it may cause severe liver damage if consumed.