Bayer has received approval in India to expand the use of its cancer drug, Nubeqa (darolutamide), for treating adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen-deprivation therapy (ADT). This approval offers a crucial non-chemotherapy option, particularly for patients unable to tolerate chemotherapy.

Nubeqa was launched in India in June 2022 with its first approved indication for non-metastatic castration-resistant prostate cancer (nmCRPC), followed in 2023 by approval for its use together with docetaxel and ADT in metastatic disease.

Shweta Rai, Managing Director - India and Country Division Head - South Asia, Bayer’s Pharmaceutical Division, said, “We are committed to advancing access to innovations that address significant unmet needs in India. India’s growing involvement in global clinical trials plays an important role in developing therapies that reflect real-world patient diversity and treatment requirements. The expanded indication of Nubeqa strengthens our efforts in prostate cancer care by providing an additional option for men at advanced stages, particularly those who are ineligible for chemotherapy. With this approval, we remain focused on enabling wider access to evidence-based, better-tolerated treatments that support patients in living longer and with an improved quality of life.”

Prostate cancer is the most prevalent malignancy among Indian men over 50, with cases expected to rise as the population ages. This rising trend underscores the urgent need for advanced, well-tolerated treatment options that prioritize patient quality of life.

The expanded approval is supported by data from the global Phase III clinical study called ARANOTE that evaluated darolutamide plus ADT in men with metastatic hormone-sensitive prostate cancer. India played an important role in this trial, with 93 patients enrolled, representing about 14% of the global study population. AIIMS Delhi served as a key trial site, along with additional centres across the country.

Nubeqa (darolutamide) developed jointly by Bayer and Orion Corporation, is a next-generation androgen receptor inhibitor designed with a unique structure that results in minimal blood–brain barrier penetration, reducing the likelihood of fatigue or cognitive concerns seen with some earlier AR inhibitors. It also has low potential for drug–drug interactions, making it suitable for older patients or those managing multiple therapies.

Dr. Atul Batra - Additional Professor, Department of Medical Oncology from AIIMS, Delhi, said “India’s growing contribution to global clinical trials is crucial because it ensures that treatment advances reflect the diversity and real-world needs of our population. With 14% of enrolment coming from India for the global Phase III clinical study (ARANOTE), these findings give clinicians confidence that darolutamide is a relevant and effective option for Indian patients with advanced prostate cancer.”

Nubeqa is approved globally in approximately 89 countries for the treatment of mHSPC and nmCRPC, reflecting its growing role in helping clinicians manage advanced prostate cancer with evidence based, well tolerated treatment options. The latest indication for mHSPC is approved in Korea, Thailand, Taiwan, Australia, US, the EU and now India.