US FDA approves Pfizer’s PARP inhibitor for metastatic breast cancer
The US Food and Drug Administration (FDA) approved Talzenna (talazoparib), a poly ADP-ribose polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.
A spokesperson from Pfizer told us, “PARP inhibitors inhibit and trap PARP enzymes on damaged DNA, which may lead to tumor cell death. Patients with gBRCA-mutated breast cancer are often diagnosed at a younger age, and until recently, these individuals have had limited effective options to treat their specific disease.”
Marc Rothenberg, chief development officer of oncology at Pfizer, explained in a statement that this approval is significant as it has shown progression-free survival in comparison with physician choice chemotherapy.
A spokesperson from the FDA told us, that Talzenna approval gives patients an additional option of treatment. AstraZeneca’s PARP inhibitor, Lynparza (olaparib), was approved by the FDA in January 2018.
Pfizer said in a press release that the approval of Talzenna demonstrates Pfizer’s successful application of precision medicine in drug development. “In this case targeting the faulty DNA damage repair (DDR) process associated with BRCA mutations,” said the spokesperson.
Pfizer’s spokesperson told us that Talzenna is also being evaluated in several ongoing clinical trials in breast and other cancers, including early triple negative breast cancer (TNBC), ovarian and prostate cancers. It is also being tested as a combination treatment with targeted immunotherapies therapies in solid tumors.