The Drug Controller General of India (DCGI) has asked regulators in all states and Union Territories to withdraw AstraZeneca's cancer drug Olaparib. The DCGI stated the anti-cancer drug that is mostly used to treat patients with gBRCA mutation, and those with advanced ovarian cancer & breast cancer is said to have adverse effects. The regulators have been asked to direct the manufacturers to discontinue the marketing of this drug.
So what is Olaparib and what does it do?
Olaparib is a medication also known as a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor. It is primarily used as a cancer treatment drug to treat different types of cancers including ovarian, breast, prostate, and pancreatic cancers. They are usually used as a last resort and prescribed to patients with advanced cancers who haven't responded to any other drug treatments.
Their main mechanism is to block the PARP enzyme, which helps to repair DNA damage in cells. In cancer cells that have specific genetic mutations like BRCA1 and BRCA2, this inhibition will slow down the progress of cancer cells.
Based on the subgroup analysis of patients who received three or more prior lines of chemo, patients who were taking this drug potentially had shorter survival chances than the ones who didn't take the drug.Dr. Abhishek Shankar, Assistant Professor, Department of Radiation Oncology, Dr. BR Ambedkar Institute Rotary Cancer Hospital at AIIMS, Delhi
On May 16th, a communication was sent by the pharmaceutical company/ firm 'AstraZeneca' to the regulators. The DCGI stated that they've submitted an application with clear evidence to withdraw the use of Olaparib Tablets 100mg and 150mg for patients with gBRCA mutation and advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. It was added that the drug can continue to be marketed for other approved indications only.
The 100mg and 150mg Olaparib tablets were initially approved by the DCGI on August 13th, 2018 for treating patients with ovarian and certain forms of breast cancer.
Dr. Abhishek Shankar, Assistant Professor, Department of Radiation Oncology, Dr. BR Ambedkar Institute Rotary Cancer Hospital at AIIMS, Delhi, told IANS that the decision to withdraw Olaparib is justified for patients with deleterious or suspected deleterious germline BRCA-mutated advanced cancer who have been treated with three or more prior lines of chemotherapy. Based on the subgroup analysis of patients who received three or more prior lines of chemo, patients who were taking this drug potentially had shorter survival chances than the ones who didn't take the drug.
The US FDA had indicated the withdrawal of this drug on March 26th.
(Input from various sources)
(Rehash/Aditi Madathingal)