CDSCO approves AstraZeneca Pharma India’s liver cancer drug Tremelimumab Concentrate for intravenous administration
Published Date – 06:20 AM, Fri – 2 June 23
Photo: IANS
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has approved AstraZeneca Pharma India’s liver cancer drug Tremelimumab Concentrate for intravenous administration, the company said on Thursday.
The approval of tremelimumab in combination with durvalumab is based on results from a phase III trial for the treatment of patients with unresectable hepatocellular carcinoma (uHCC), the most common type of primary liver cancer.
The trial, conducted in 16 countries, including India, the U.S. and Canada, showed that the combination of tremelimumab and durvalumab had a positive effect on overall survival compared with sorafenib, the company said in a statement. and significant benefits.
It added that the approval paves the way for the launch of Tremelimumab solution at 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml in single-dose vials) in India for specific indications.
“Patients with unresectable liver cancer often have a limited prognosis and a significant delay in diagnosis, with the majority of cases being diagnosed at advanced and unresectable stages. New treatment options are therefore critical to improve long-term survival,” said AstraZeneca India Medical Dr Anil Kukreja, vice president for affairs and regulation, said in the statement.
The phase III trial included a regimen that included a single starting dose of tremelimumab 300 mg added to durvalumab 1500 mg, followed by durvalumab every 4 weeks with the standard-of-care multikinase inhibitor sorafenib.
A total of 1,324 patients with unresectable advanced HCC who had not received prior systemic therapy and were not eligible for local therapy (localized treatment of the liver and surrounding tissues) were included in the trial.
Globocan India 2020 reports that more than 30,000 new native cases of hepatocellular carcinoma (HCC) are diagnosed each year, making it the 10th most common cause of cancer in India. Its high mortality rate makes it the eighth most common cause of cancer-related death in the country.
Common causes and risk factors for HCC in India include cirrhosis, hepatitis B and C infection, alcohol, smoking, diabetes, and nonalcoholic fatty liver disease.
The 5-year survival rate for HCC is approximately 18%; the 5-year overall survival rates for localized, regional, and metastatic HCC are 33%, 10%, and 2%, respectively.
