EMA Greenlights Four Drugs for Bladder and Other Cancers

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Bladder Cancer News

Malignant Bladder Neoplasm,Drug/Treatment Safety,Drug Safety

The positive opinions pave the way for new treatment options in Europe for urothelial carcinoma, prostate cancer, lymphoma, and leukemia.

At its June 27 meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended granting marketing authorizations for four cancer therapies. The CHMP endorsed the approval of Balversa , intended for the treatment of urothelial carcinoma, a type of cancer affecting the bladder and urinary system.

Relapsed or refractory diffuse large B‑cell lymphoma after two or more lines of systemic therapyin heavily pretreated patients who had not received chimeric antigen receptor T-cell therapy. A total of 31% achieved a complete response. an 82% response rate in patients with grades I-IIIA disease, with 75% of the overall population achieving a complete response.

Enzalutamide Viatris will be available as 40-mg and 80-mg film-coated tablets. The active substance of Enzalutamide Viatris is enzalutamide, a hormone antagonist that blocks multiple steps in the androgen receptor–signaling pathway.

 

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