The company claims that Apalutamide will play a role in significantly improving overall survival (OS) and radiographic progression-free survival in patients.
BDR Pharmaceutical on Tuesday announced that it has launched the first generic Apalutamide (Brand name APATIDE) in India to treat metastatic castration-sensitive Prostrate cancer and non-metastatic castration-resistant Prostrate cancer.
According to the company, 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, the company claims.
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“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% amongst Non-Metastatic Castration-resistant Prostrate Cancer. The drug promises quality of life as measured by the complete Functional Assessment of the Cancer Therapy-Prostate,” the company stated on Tuesday.
The prostate cancer’s 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. In India, Prostate cancer is the second most common cause of cancer and the sixth leading cause of cancer deaths among men.
The company claims that 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 Metastasis – 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%,” the company stated.
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The company also informed that the outcome of the study indicates that the drug can contribute to the overall health-related quality of life with its addition to androgen-deprivation therapy.
“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 & 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. 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,” Raheel Shah, Director Business Development, BDR Group said on Tuesday.
BDR Pharmaceuticals, a key player in the manufacturing of Indian Cancer medicines, has contributed to the treatment of Prostate Cancer starting with Abiraterone Acetate, then Leuprolide Acetate followed by Enzalutamide and, then Degarelix and Triptorelin.
The group focuses on development in four specialized therapeutic segments – Oncology, Critical Care, Gynecology and Neurology.
