Three withdrawals in advanced ovarian cancer spell trouble for PARP class

When AstraZeneca and Merck’s PARP inhibitor Lynparza was approved for advanced ovarian cancer back in 2014, FDA’s current Oncology Center of Excellence director Richard Pazdur touted it as the first in a “targeted, more personalized” new class of medicines for patients who often relapse after chemotherapy.

Almost a decade later, that option is once again off the table for some patients as three pharma giants yank late-stage indications from their labels over a potential increased risk of death.

GSK was the latest company to voluntarily pull its rival PARP inhibitor Zejula just over a week ago in ovarian cancer patients who are HRD-positive and have tried at least three prior chemotherapy treatments. The pharma giant said the decision was made in consultation with the FDA, based on a “totality of information” from PARP inhibitors in the later setting, namely a “potential detrimental effect on overall survival” that was observed with…
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