Bayer prostrate cancer medicine Nubeqa approved for expanded use in non-chemotherapy patients

Bayer AG logo | Photo Credit: WOLFGANG RATTAY

Multinational company Bayer said that its prostrate cancer medicine Nubeqa has received approval in India for an expanded indication , offering clinicians access to a non-chemotherapy treatment option for patients who may not be able to tolerate chemotherapy.

“The expanded approval in India allows for Nubeqa to be used in combination with androgen-deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC),” a note from the company explained. Bayer said, the latest indication for mHSPC is approved in Korea, Thailand, Taiwan, Australia, US, the EU and now India.

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, it added.

Shweta Rai, Managing Director - India and Country Division Head (South Asia), Bayer’s Pharmaceutical Division, said, “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.”

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 percent of the global study population, the note said, adding that AIIMS Delhi was a key trial site, along with additional centres across the country. In India, prostate cancer is most common in men over 50 years, the note said, adding that a growing ageing population could see an increase in cases, increasing the need for better-tolerated treatment options that help improve the quality of life in patients.

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 products, the note said. It also has low potential for drug–drug interactions, making it suitable for older patients or those managing multiple therapies, the company explained. Nubeqa is approved globally in approximately 89 countries for the treatment of mHSPC and nmCRPC.

Dr Atul Batra, Additional Professor, Department of Medical Oncology, 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 percent 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.”

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Published on February 24, 2026