Bayer secures India approval for expanded use of Nubeqa
Darolutamide plus ADT cleared for mHSPC, supported by ARANOTE Phase III data with Indian participation
Bayer has announced that its cancer drug Nubeqa has received approval in India for an expanded indication, providing clinicians access to a non-chemotherapy treatment option for patients who may not be able to tolerate chemotherapy.
The expanded approval permits the use of Nubeqa in combination with androgen-deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nubeqa was launched in India in June 2022 with its first approved indication for non-metastatic castration-resistant prostate cancer (nmCRPC). In 2023, it received approval for use in combination 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.”
In India, prostate cancer is most common in men over 50 years. As the ageing population increases, cases are expected to rise, leading to greater demand for treatment options that are effective, tolerated and support quality of life.
The expanded approval is supported by data from the global Phase III clinical study ARANOTE, which evaluated darolutamide plus ADT in men with metastatic hormone-sensitive prostate cancer. India enrolled 93 patients in the trial, 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 an androgen receptor inhibitor designed with a structure that results in minimal blood–brain barrier penetration. The drug also has low potential for drug–drug interactions.
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 in approximately 89 countries for the treatment of mHSPC and nmCRPC. The latest indication for mHSPC is approved in Korea, Thailand, Taiwan, Australia, the US, the EU and India.