Bayer has announced that its cancer therapy Nubeqa has received approval in India for an expanded indication. As a result, clinicians can now prescribe a non-chemotherapy treatment option for patients who may not tolerate chemotherapy well.
Under the expanded approval, doctors can use Nubeqa in combination with androgen-deprivation therapy (ADT) to treat adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Earlier, Bayer launched Nubeqa in India in June 2022 for non-metastatic castration-resistant prostate cancer (nmCRPC). Subsequently, in 2023, authorities approved its use in combination with docetaxel and ADT for metastatic disease.
Rising Prostate Cancer Burden in India
In India, prostate cancer most commonly affects men over 50 years of age. Moreover, as the population continues to age, the number of diagnosed cases is expected to rise steadily. Therefore, the demand for treatment options that are not only effective but also better tolerated and capable of preserving quality of life has become increasingly urgent.
ARANOTE Trial Supports Expanded Use
The expanded approval is based on data from the global Phase III clinical study, ARANOTE, which evaluated darolutamide plus ADT in men with mHSPC. Importantly, India played a significant role in this trial.
As reported by Business Standard, the study enrolled 93 patients from India, accounting for approximately 14% of the global study population. All India Institute of Medical Sciences Delhi served as a key trial site, alongside several other centres across the country.
Next-Generation Androgen Receptor Inhibitor
Bayer jointly developed Nubeqa (darolutamide) with Orion Corporation. As a next-generation androgen receptor inhibitor, darolutamide features a unique molecular structure. Consequently, it demonstrates minimal penetration of the blood–brain barrier, which reduces the likelihood of fatigue and cognitive side effects observed with some earlier androgen receptor inhibitors.
In addition, Nubeqa has a low potential for drug–drug interactions. Therefore, physicians can consider it a suitable option for older patients and for those managing multiple therapies simultaneously.
Growing Global Adoption
Currently, Nubeqa is approved in approximately 89 countries for the treatment of mHSPC and nmCRPC. This wide approval reflects its expanding role in the management of advanced prostate cancer through evidence-based and well-tolerated treatment strategies.
The latest mHSPC indication has already received approval in countries such as Korea, Thailand, Taiwan, Australia, the United States, the European Union, and now India, further strengthening its global footprint in advanced prostate cancer care.