AstraZeneca Pharma India Ltd has relinquished its marketing authorization for Olaparib tablets (traded as Lynparza) for certain cancer indications in India. This action comes after a directive from the Drug Controller General of India (DCGI) to take the drug off the market for certain patient populations because of fears of possible adverse effects and overall survival results. The firm explained that the discontinuation is commercial in nature and has nothing to do with the drug's safety or efficacy in other indications.
Key Points
-
The DCGI has directed the withdrawal of AstraZeneca's Olaparib tablets for the treatment of patients with gBRCA mutation and advanced ovarian cancer or breast cancer who have had three or more previous lines of chemotherapy.
-
The choice is grounded in a post hoc subgroup analysis suggesting a possible harmful impact on overall survival for Olaparib versus chemotherapy in this particular patient subgroup.
-
AstraZeneca Pharma India had filed an application to withdraw these indications, and state regulators have been directed to instruct all manufacturers to stop marketing Olaparib tablets for these purposes and revise the package inserts accordingly.
-
The medication can still be sold for other indications that have been approved, including maintenance therapy in other cancer subtypes or patient groups.
-
The withdrawal is consistent with similar moves in other nations, including the US FDA's previous decision to limit Olaparib's use in this patient group.
-
AstraZeneca insisted that the discontinuation is based on commercial considerations and not due to doubts over the efficacy or safety of the drug in its other indications.
-
Olaparib, which is a PARP inhibitor, is still on the market for other indications where it still shows clinical benefit.
Sources Economic Times Times of India CNBC TV18 Hindustan Times