The product will be available across India and shall be of 60 mg strength and available in two packs – 60 tabs and 120 tabs
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 Prostrate Cancer patients. Apalutamide plus ADT (androgen-deprivation therapy) arm shows a significant decrease in the risk of disease progression and reduces the 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 the cancer therapy prostate.
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 Metastatis – 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 to 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 and introduction of products through the strength of backward integration of developing and manufacturing APIs to facilitate humankind. This type of advanced molecule in the treatment of various cancer indications is testimony towards our commitment to providing access to affordable medicines without compromising patients’ safety as well as qualitative standards.”
