Drug Approval | May 15, 2026
Alembic Pharma receives USFDA tentative approval for Darolutamide tablets
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
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
Opaganib has shown potential in enhancing ARPI treatment by blocking multiple enzymes involved in cancer cell survival.
In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
Despite the strong results, investigators cautioned that the study has limitations, including its open-label Phase II design, lack of randomization, and reliance on a historical external control arm
Prostate cancer is one of the fastest-growing cancers in India, with approximately 37,948 new cases each year
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
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