Cancer Treatment Drugs namely Vitrakvi, Xospata and Truxima Approved by FDA

Three drugs namely Vitrakvi, Xospata and Truxima have been approved by the US Food and Drug Administration on Monday, to treat cancer patients.  The cancer treatment is based on the tumor biomarker (cancer having specific generic feature) rather than the place where the tumor had developed.

The drug Vitrakvi would be used for the treatment of solid tumors where surgical removal is likely to cause serious conditions and the tumors which have Neurotrophic Receptor Tyrosine Kinase (NRTK) which is known to be a high affinity nerve growth factor receptor,  that caused mutation in the gene, which causes of intellectual disability or congenital insensitivity to pain with anhidrosis(inability to sweat that result in fatal conditon and also in metastatic cancer, where the cancer cells spread to new areas through blood.

According to FDA, Xospata tablets, which was approved on Wednesday, are for the treatment of adult patients who suffer from refractory acute myeloid leukemia (AML) with an FLT3 mutation, which is detected by FDA approved the test.  Along with the tablets, the agency has also approved a diagnostic test to detect the mutation.  Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence say that about 25-30% of patient with AML have a mutation in the FLT3 gene, which are a progressive form of the disease, that affects the numbers of normal blood cells and needs continuous transfusions of blood to save the life.

Truxima, the first biosimilar of Rituximab (Rituxan) to treat adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL)and for the treatment of hematological cancers had been approved by FDA according to Celltrion (a biopharmaceutical company headquartered in Incheon, South Korea) on Wednesday.  With the latest drug, Rituximab expected the amount of sales may be about $4.45 billion in the U.S.  Truxima can be used as a single agent or in combination with chemotherapy, according to the agency.

FDA commissioner Scott Gottlieb says that they are making new policies for the development of biosimilars and to give more opportunities for biosimilar manufacturers to make these products successful and competitive with a view to help more patients.