Why the FDA withdrew support for PARPi

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

https://tinyurl.com/3mrm6z4r

The recent decision by the FDA to withdraw access to PARP inhibitors for patients with recurrent ovarian cancer has raised issues about the approval process and questions about the efficacy of these drugs

Personalised therapy with enzyme inhibitors such as PARPi has revolutionised the treatment of ovarian cancer. The success, in terms of increased survival, led to pressure for the use of such drugs to be expanded beyond the initial target group to more women.

Real-world experience often causes reappraisal of the benefits and it is now clear that use of PARPi for treatment of recurrent ovarian cancer increases the likelihood of major adverse effects such as marrow suppression. A decrease in survival compared to standard therapy was also seen and long-term use of PARPi reduces the effectiveness of standard platinum-based chemo.

All of these drugs benefited from accelerated approval processes. Recent decisions by the FDA to approve some expensive drugs with contentious experimental evidence, such as aducanumab for dementia, have caused criticism of the accelerated process. The withdrawal of these PARPi drugs will increase the scrutiny and may result in unavoidable delays to important changes in cancer treatment.