Idelalisib has captured the attention of pharmaceutical research and development teams with the latest data touting its targeted treatment for both unresectable non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The FDA accepted Gilead Sciences’ new drug application early in 2014 for the treatment of refractory indolent NHL, and the target review date for the PDUFA is set for August 6, 2014. A green light for Idelalisib is expected later this summer as this unique P13K delta inhibitor has proven viable both as a single agent and in combination with other anti- cancer drugs. The ability of Idelalisib to target the P13 kinase delta gene variation effectively helps stop the growth and proliferation of cancer cells. As an option for patients with NHL and CLL, Idelalisib has proven in studies to fight metastatic CLL with full force.
Studies involving patients who received Idelalisib and Rituximab showed exemplary results with more than 70 percent of participants exhibiting overall survival improvement. Results from a successful Phase lll study, which was presented at the 55th Annual Meeting of the American Society of Hematology were favorable for patients who were administered Idelalisib adjunctively with Rituximab. This study, also coined Study 116 involved 220 patients at 70 individual sites in the United States and Europe. Phase ll study results were also presented at the aforementioned meeting, which showed a 57 percent response rate for patients who were dosed with Idelalisib. These patients gleaned an average of 12 ½ months of progression free survival as well.
Patients diagnosed with chronic lymphocytic leukemia make up 16,000 new cancer diagnoses each year in America. While CLL is a slow growing cancer the options for varied treatment to date have remained limited. The advent of Idelalisib to the repertoire of drug treatments made available to people offers new hope for this patient population. Indolent non-Hodgkin’s lymphoma is currently an incurable disease that is slow growing, like CLL. Patients with iNHL unfortunately suffer from dire health issues earlier in the progression of the disease, like bone marrow failure and serious infections. The use of Idelalisib for the opportunity to extend the lifespan and keep the progression of this debilitating disease from advancing so quickly is essential for these patients.
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