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In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

A rolling submission of a New Drug Application for umbralisib has been initiated by drug developer, TG Therapeutics, Inc, which is requesting accelerated approval of the agent from the FDA for the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma. The company reported in a press release that one application was considered to be acceptable for both drugs and the NDA will be completed in the first half of 2020.<br /> &nbsp;

The phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in patients with advanced T-cell lymphomas, has been placed on a partial clinical hold by the FDA. The decision was made following discussions regarding Good Manufacturing Practice deficiencies at a subcontractor site that manufacturers the agent&nbsp;in December of 2019, according to a press release from Innate Pharma SA.

A new drug application for selinexor has been submitted to the FDA for the treatment of patients with relapsed or refractory diffuse large b-cell lymphoma who have had at least 2 prior multi-drug therapies,and who are ineligible for stem cell transplantation, including chimeric antigen receptor T-cell therapy, according to a press release from Karypharm Therapeutics, developer of selinexor.<br /> &nbsp;