FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status
On Tuesday, May 26, 2009, Allos Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company’s New Drug Application (NDA) for the use of pralatrexate (PDX) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Allos also announced that the FDA has granted the NDA priority review status date of September 24, 2009 for a decision regarding the NDA.
Peripheral T-cell lymphomas comprise 10 to 15 percent of all non-Hodgkin lymphomas (NHL) in adults. The term peripheral T-cell lymphoma (PTCL) is based on the fact that these are tumors composed of T-cells and that the cells are mature. Most peripheral T-cell lymphomas are aggressive, with the exception of mycosis fungoides (CTCL), mentioned above with the indolent or low grade lymphomas. Peripheral T-cell lymphomas such as angioimmunoblastic T-cell lymphoma or anaplastic large cell lymphoma can arise in lymph nodes, while others like subcutaneous panniculitis-like T-cell lymphoma, nasal NK/T-cell lymphoma, or intestinal T-cell lymphoma can arise in extranodal sites. These tumors are not well understood, but they are usually aggressive and have widespread involvement at diagnosis.
To read the press release issued by Allos Therapeutics, Inc., please click here.
To learn more about PTCL, you can view available webcasts or view/download LRF's PTCL fact sheet online.
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