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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;

Complete remissions were achieved in greater than 20% of patients&nbsp;with highly refractory non-Hodgkin lymphomas who had been&nbsp;previously been treated with chimeric antigen receptor T-cell therapy with&nbsp;Mosunetuzumab, a novel bispecific antibody,&nbsp;according to study results presented at the 2019 American Society of Hematology Annual Meeting.

In November 2019, the FDA approved a number of treatments, including acalabrutinib for the treatment of chronic lymphocytic leukemia and small lymphocytic leukemia, as well as zanubrutinib for the treatment of mantle cell lymphoma. A biosimilar for pegfilgrastim was also approved under indications.

Hodgkin lymphoma represents approximately 10% of all cases of malignant lymphoma. This group of diseases most commonly affects adolescent and young adults, although approximately 20% to 25% of patients are aged &ge;60 years at diagnosis. Advanced-stage disease is generally classified as Ann Arbor stage III to IV, but clinical trials often incorporate patients with high-risk stage II disease, such as those with B symptoms, multiple sites, or bulky disease