The Drug Controller General of India (DGCI) has asked the drug regulators of all states and union territories to allow AstraZeneca's anti-cancer drug 'Olaparib' (Olaparib) for the treatment of those patients. Withdraw Olaparib) who have received chemotherapy 3 or more times.
Orders regarding these matters
State regulators are directed to direct the manufacturers of the drug to stop marketing the drug for the treatment of patients with gBRCA mutation and late stage ovarian cancer and breast cancer due to potential adverse effects and to submit a revised packaged entry. Having said. The top drug regulator has said that marketing of the drug can be continued for other approved indications.
Why was this order given?
AstraZeneca had obtained the approval of 'Olaparib' in the year 2018, but the company had recently submitted an application in which it was requested to withdraw the drugs in 100 mg and 150 MD doses for patients with GBRCA mutation. . This decision comes after post-hoc subgroup analysis indicated a potential detrimental effect on overall survival when comparing olaparib to the chemotherapy control arm in this specific patient subgroup.
Ovarian cancer
Ovarian cancer occurs in women when abnormal cells start growing in a woman's ovaries or fallopian tubes and go out of control. The ovaries are part of the female reproductive system. These two round, walnut-sized organs produce eggs during your productive years.
Breast cancer
Breast cancer occurs when breast cells mutate and become cancerous cells which multiply and form tumors. Breast cancer is generally considered a women's disease, but in some cases it can happen to men too. There is a continuous increase in the patients of this disease in India.
(PC: Freepik)
