New Delhi: The Drug Controller General of India has asked drug regulators of all states and union territories to recall AstraZeneca's anti-cancer drug Olapari tablets for the treatment of patients who have received chemotherapy three or more times.
State regulators have been asked to direct the drug's manufacturers to stop marketing the drug to treat patients with GBR mutation and advanced ovarian cancer and breast cancer due to potential adverse effects and submit a revised package insert.
The drug regulator said the drug could continue to be marketed for other approved indications.
In a communication sent to regulators on May 16, the DCGI said the company AstraZeneca Pharma India Ltd has received an application from them to withdraw the indications for Olaparib tablets 100 mg and 150 mg in the treatment of patients with GBRCA mutation and advanced ovarian cancer. presented. Those who have been treated with three or more prior chemotherapy.“Based on post hoc subgroup analysis, there is evidence indicating a potentially detrimental effect on overall survival of olaparib compared to the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy.
"The matter has been reviewed in consultation with SEC (Oncology) experts in the meeting held at CDSCO on 19.03.2024 and 20.03.2024," the communication said.
The communication said the firm presented clinical evidence to withdraw the indication for Olaparib tablets.
"In view of the above circumstances, you are requested to advise all the manufacturers of the said drug under your jurisdiction to withdraw the marketing of the product Olaparib Tablets 100 mg and 150 mg approved by your office and submit the revised package insert. The drug may continue to be marketed for other approved indications.,
The communication said the 100 mg and 150 mg tablets were approved by DCGI on August 13, 2018, for the treatment of adult patients with ovarian cancer and some forms of breast cancer.
State regulators have been asked to direct the drug's manufacturers to stop marketing the drug to treat patients with GBR mutation and advanced ovarian cancer and breast cancer due to potential adverse effects and submit a revised package insert.
The drug regulator said the drug could continue to be marketed for other approved indications.
In a communication sent to regulators on May 16, the DCGI said the company AstraZeneca Pharma India Ltd has received an application from them to withdraw the indications for Olaparib tablets 100 mg and 150 mg in the treatment of patients with GBRCA mutation and advanced ovarian cancer. presented. Those who have been treated with three or more prior chemotherapy.“Based on post hoc subgroup analysis, there is evidence indicating a potentially detrimental effect on overall survival of olaparib compared to the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy.
"The matter has been reviewed in consultation with SEC (Oncology) experts in the meeting held at CDSCO on 19.03.2024 and 20.03.2024," the communication said.
The communication said the firm presented clinical evidence to withdraw the indication for Olaparib tablets.
"In view of the above circumstances, you are requested to advise all the manufacturers of the said drug under your jurisdiction to withdraw the marketing of the product Olaparib Tablets 100 mg and 150 mg approved by your office and submit the revised package insert. The drug may continue to be marketed for other approved indications.,
The communication said the 100 mg and 150 mg tablets were approved by DCGI on August 13, 2018, for the treatment of adult patients with ovarian cancer and some forms of breast cancer.
