Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments
HIFU is a state-of-the-art treatment that utilizes high-frequency sound waves to target and destroy prostate cancer cells
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in this patient population, supporting its earlier use in this setting
Xtandi is approved in over 80 countries, including the U.S., EU, and Japan
Robust pipeline with around 50 projects in clinical development / cardiology portfolio poised for growth with launch products Kerendia (finerenone) and Verquvo (vericiguat)
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