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
Prostate cancer is one of the fastest-growing cancers in India, with approximately 37,948 new cases each year
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
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer
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%
On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors
Darolutamide is developed jointly by Bayer and Orion Corporation
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