The FDA has granted orphan drug status Daratumumab the treatment of multiple myeloma (MM) of

Recently, the first monoclonal antibody drug Daratumumab by the US Food and Drug Administration (FDA) approved for the treatment of multiple myeloma (MM). For at least three kinds of therapy by the patients, the drug is an excellent treatment option.
FDA said the two open studies have demonstrated the safety and effectiveness of the drug. One study included 106 patients with MM and give daratumumab treatment, the results are 29% of the patients had a complete tumor burden or partial reduction, and lasted an average of 4.7 months. And another study, 42 MM patients received the drug treatment, the results of 36% of the patients had a complete tumor burden or partially reduced. The researchers said that to ease daratumumab produced is "unprecedented".
Professor Peter Voorhees said the study 106 patients received daratumumab monotherapy, and 29% of patients had a remission. What is more, 95% of all patients on protease inhibitor and lenalidomide therapy has become resistant. In addition, its ease lasting effect. More importantly, none of the patients in the study because of side effects associated daratumumab stop treatment.
FDA said the drug's side effects include infusion reactions, fatigue, nausea, back pain, fever and cough, and may cause lymphopenia, neutropenia, leukopenia, anemia and thrombocytopenia. This medicine should not be used during pregnancy Women, pregnancy or the wishes of the patient must stop taking this medicine for effective contraception after three months.
In addition, daratumumab may affect some blood bank tests (eg, antibody screening, etc.).
Daratumumab is the first anti-human CD38 monoclonal antibody, induces cell death through multiple mechanisms. The drug is given priority review by the FDA's accelerated approval. FDA granted the drug for the treatment of multiple myeloma orphan drug status.