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Treatment of people aged 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy [2]
In June 2022, due to safety concerns, the US Food and Drug Administration (FDA) withdrew its approval for Ukoniq (umbralisib). [3] Updated findings from the UNITY-CLL clinical trial show a possible increased risk of death in people receiving Ukoniq. [3] As a result, the FDA determined the risks of treatment with Ukoniq outweigh its benefits. [3]
In November 2013, the US Food and Drug Administration (FDA) approved obinutuzumab in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia, and was the first drug with breakthrough therapy designation to gain approval. [19] [20]
Chronic lymphocytic leukemia (CLL) is a type of cancer that affects the blood and bone marrow. [8] [9] In CLL, the bone marrow makes too many lymphocytes, which are a type of white blood cell. [8] [9] Many people do not have any symptoms when they are first diagnosed. [8] [2] Those with symptoms may experience fevers, fatigue, night sweats, and ...
In the EU, venetoclax monotherapy is indicated for the treatment of chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adults who are unsuitable for or have failed a B cell receptor pathway inhibitor and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adults who have failed both ...
Mosunetuzumab, sold under the brand name Lunsumio, is a monoclonal antibody used for the treatment of follicular lymphoma. [2] [3] [5] It bispecifically binds CD20 and CD3 to engage T-cells. [2] [3] It was developed by Genentech. [6] The most common adverse reactions (≥20%) include cytokine release syndrome, fatigue, rash, pyrexia, and headache.
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