Lymphoma
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With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
Citius Pharmaceuticals’ Lymphir is a reformulated version of denileukin diftitox—an FDA-approved cancer therapy—and the only treatment for cutaneous T cell lymphoma that targets the IL-2 receptor located on malignant T cells and Tregs.
The specialty pharmaceutical company has twice filed for bankruptcy in recent years, driven by opioid-related litigation. Mallinckrodt’s deal with CVC will allow it to pay off more than half of its net debt.
AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma.
National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents.
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy.
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.
ADC Therapeutics is positioning Zynlonta for a label expansion with new Phase II data showing that the treatment can elicit high rates of complete response in patients with relapsed or refractory marginal zone lymphoma.
AstraZeneca’s blockbuster BTK inhibitor Calquence significantly improved progression-free survival when used as a frontline treatment in patients with mantle cell lymphoma, according to Thursday’s late-stage results.
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