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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 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