FDA Grants Fast Track Designation to Ublituximab Plus Umbralisib in Chronic Lymphocytic Leukemia
Dec. 8, 2016 – The European Commission (EC) has approved venetoclax (Venclyxto) as a first-in-class, oral, once-daily medicine that selectively inhibits the function of the BCL-2 protein.1 BCL-2 prevents the natural death of cells, including CLL cells.1 The EC has granted conditional marketing authorization for venetoclax monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) patients with 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL patients without 17p deletion or TP53 mutation who have failed both chemoimmunotherapy (such as fludarabine/cyclophosphamide/rituximab (FCR), OR bendamustine/rituximab (BR)and a B-cell receptor pathway inhibitor (such as ibrutinib or idelalisib).1
CLL, a cancer of the bone marrow and blood, is typically a slow-progressing cancer.2 The 17p deletion, where a part of chromosome 17 is absent, is found in 3 to 10 percent of untreated CLL patients and up to 30 to 50 percent of relapsed or refractory CLL patients.3 A TP53 mutation occurs in 8 to 15 percent of untreated patients and up to 35 to 50 percent of patients with refractory CLL.3 Those patients with the 17p deletion or TP53 mutations often have a particularly poor prognosis3 and a median life expectancy of less than two to three years with current standard-of-care regimens.4
“Results from the clinical trial program show that venetoclax provides significant overall response among both patients with previously treated CLL with 17p deletion and patients with CLL who had been previously treated with and failed a B-cell receptor inhibitor,” said Stephan Stilgenbauer, M.D., Ulm University, Germany, investigator in the venetoclax clinical trial program. “While advances in treatment over the past few years have been meaningful for patients in Europe living with CLL, new options are still needed.”
1Summary of Product Characteristics for VENCLYXTO.
2American Cancer Society (2015). Leukemia – Chronic Lymphocytic. http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf. Accessed December 2016.
3Schnaiter A, et al. 17p deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach. Hematol Oncol Clin N Am. 2013; 27:289-301.
4Stilgenbauer S, et al. Understanding and managing ultra high-risk chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program. 2010; 1:481-488.
Read more at:
http://www.pharmatimes.com/news/abbvies_venclyxto_okd_in_europe_for_cll_1180791
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