New Delhi: The Drug Controller General of India (DCGI) has instructed drug regulators in all states and Union territories to withdraw AstraZeneca’s anti-cancer drug Olaparib tablets for patients who have undergone three or more prior lines of chemotherapy.
State regulators have been directed to instruct manufacturers to cease marketing Olaparib for the treatment of patients with gBRCA mutations and advanced ovarian and breast cancer due to potential adverse effects. Manufacturers are also required to submit revised package inserts.
The drug may continue to be marketed for other approved indications, according to the DCGI.
In a communication sent on May 16, the DCGI stated that AstraZeneca Pharma India Limited had submitted an application to withdraw the indication of Olaparib Tablets 100mg and 150mg for the treatment of patients with gBRCA mutations and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
“Based on a post hoc subgroup analysis indicating a potential detrimental effect on overall survival for Olaparib compared to the chemotherapy control arm in patients who had received three or more prior lines of chemotherapy, the matter has been reviewed in consultation with SEC (Oncology) experts during a meeting held on March 19-20, 2024 at CDSCO,” the communication stated.
AstraZeneca presented clinical evidence supporting the withdrawal of this indication for Olaparib tablets.
“In light of these circumstances, you are requested to direct all manufacturers of the drug under your jurisdiction to withdraw marketing of Olaparib Tablets 100mg and 150mg approved by your office, and submit the revised package insert. The drug may continue to be marketed for other approved indications,” the communication added.
Olaparib Tablets 100mg and 150mg were initially approved by the DCGI on August 13, 2018, for the treatment of adult patients with ovarian cancer and certain forms of breast cancer.
