Glenmark launches Winlevi across key European markets

First-in-class topical androgen receptor inhibitor marks Glenmark’s first New Chemical Entity (NCE) launch in Europe

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

Bayer introduces chemo-free treatment option for advanced prostate cancer in India

Prostate cancer is one of the fastest-growing cancers in India, with approximately 37,948 new cases each year

China nod to Darolutamide for metastatic hormone-sensitive 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

Enzalutamide leads to 40% lower risk of death in prostate cancer

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

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)

Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting

Xtandi is approved in over 80 countries, including the U.S., EU, and Japan

Astellas and Pfizer’s XTANDI shows overall survival in metastatic hormone-sensitive prostate cancer

Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer

Cosmo and Glenmark receives UK MHRA approval to market Winlevi in UK