BDR launches generic Apalutamide to treat prostate cancer

BDR Pharmaceutical has launched the first generic Apalutamide (Brand name Apatide) in India to treat metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). The product will be available across India and shall be of 60 mg strength and available in two packs of 60 tabs and 120 tabs each. Apalutamide in combination with anti-androgen therapy will significantly improve chances for survival among mCSPC patients.

On the other hand, Apalutamide plus androgen-deprivation therapy (ADT) shows a significant decrease in the risk of disease progression and reduces the risk of mortality by 35 per cent among nmCRPC patients. The drug promises quality of life as measured by the complete functional assessment of cancer therapy-prostate, offering radiographic progression-free survival in patients. As per the clinical data recorded during the SPARTAN trial for patients with nmCRPC, Apalutamide in combination with anti-androgen therapy significantly improved median metastasis-free survival by two years.

The median progression-free survival for Apalutamide plus ADT arm was 40.5 months v/s 14.7 months for the placebo plus ADT arm, representing a significant decrease in the risk of disease progression or death by 71 per cent. Moreover, the patient’s reported outcomes indicate a maintained overall health-related quality of life. Raheel Shah, Director Business Development, BDR Group said, “Early identification of newer molecules for life-threatening diseases encourage us to advance the development and introduction of products through the strength of backward integration of developing and manufacturing APIs.”