BDR Pharma launches first generic apalutamide to treat prostate cancer in India

Our Bureau, MumbaiTuesday, January 3, 2023, 16:00 Hrs  [IST]

BDR Pharmaceutical has launched the first generic apalutamide (brand name Apatide) in India to treat both metastatic castration sensitive prostate cancer as well as non-metastatic castration resistant prostate cancer.

The product will be available across India and shall be of 60 mg strength and available in two packs – 60 tabs and 120 tabs. Apalutamide in combination with anti-androgen therapy will significantly improve chances for survival within metastatic castration sensitive prostate cancer patients. Apalutamide plus ADT (androgen-deprivation therapy) arm shows a significant decrease in the risk of disease progression and reduces risk of mortality by 35 per cent amongst non-metastatic castration resistant prostate cancer. The drug promises quality of life as measured by the complete functional assessment of cancer therapy-prostate.

BDRs journey for the treatment of prostate cancer started with abiratarone acetate, then leuprolide acetate followed by enzalutamide and, then degarelix and triptorelin. Worldwide, the prostate cancer burden is expected to grow to 1.7 million new cases and 4, 99,000 new deaths by 2030 simply due to the growth and aging of the global population. And in India, prostate cancer is the second most common cause of cancer and the sixth leading cause of cancer deaths among men, the world over. Information accessibility among the people regarding the disease is at its minimum level with zero acceptance.

Therefore, apalutamide will play a role in significantly improving overall survival (OS) and radiographic progression-free survival in patients. As per clinical data during SPARTAN trial for patients in non-metastatic castration resistant prostate cancer, apalutamide in combination with anti-androgen therapy significantly improved median metastatic – free survival by 02 years. The median progression free survival for apalutamide plus ADT arm was 40.5 months v/s 14.7 months for the Placebo arm plus ADT, representing a significant decrease in the risk of disease progression or death by 71 per cent. Also, patients' reported outcomes indicate maintained overall health related quality of life with the addition of apalutamide to androgen-deprivation therapy.

Raheel Shah, director business development, BDR Group stated that “Early identification of newer molecules for life-threatening diseases encourages us to advance the development & introduction of products through the strength of backward integration of developing & manufacturing APIs to facilitate humankind. This type of advanced molecule in the treatment of various cancer indications, is testimony towards our commitment in providing access to affordable medicines without compromising patients’ safety as well as qualitative standards. At BDR, our goal is to support the vision of the Honourable Prime Minister on being Atmanirbhar Bharat and make affordable and quality medicines accessible for the people of India.”

As a key player in the manufacturing of Indian cancer medicines, BDR Pharmaceuticals propagates pan India affordability and is recognized as a “niche” entity in manufacturing of pharmaceutical APIs and for the renowned new age formulations. BDR Group of companies has grown steadily and become a household name in the pharmaceutical Industry over the last 15 years, in both domestic and international arenas. The group focuses on development in four specialized therapeutic segments – oncology, critical care, gynaecology & neurology.