Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Shahzad, Mahnum; Naci, Huseyin; Esselen, Katharine M.; Dottino, Joseph A.; Wagner, Anita K.

doi:10.1080/20523211.2024.2351003

Journal of Pharmaceutical Policy and Practice

2024

DOI: 10.1080/20523211.2024.2351003

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Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Mahnum Shahzad,

Huseyin Naci,

Katharine M. Esselen

et al.

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Genetic Implications for Cancer Management: The Changing Landscape of Poly (ADP-ribose) Polymerase Inhibitor Indications in the Treatment of Ovarian Cancer

Walsh

2024

Clinical Obstetrics &Amp; Gynecology

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Between December 2014 and May 2020, the United States Food and Drug Administration approved 9 indications for poly (ADP-ribose) polymerase (PARP) inhibitor use in ovarian cancer. Between June 2022 and September 2022, all 3 indications for PARP inhibitor treatment of recurrent ovarian cancer were withdrawn. Between November 2022 and September 2023, all 3 indications for PARP inhibitor maintenance therapy in recurrent ovarian cancer were restricted. The 3 indications for PARP inhibitor maintenance therapy in newly diagnosed advanced ovarian cancer are unchanged. This article reviews the timelines and data leading to regulatory changes for PARP inhibitor use in ovarian cancer in the United States.

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Genetic Implications for Cancer Management: The Changing Landscape of Poly (ADP-ribose) Polymerase Inhibitor Indications in the Treatment of Ovarian Cancer

Walsh

2024

Clinical Obstetrics &Amp; Gynecology

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Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Cited by 1 publication

References 33 publications

Genetic Implications for Cancer Management: The Changing Landscape of Poly (ADP-ribose) Polymerase Inhibitor Indications in the Treatment of Ovarian Cancer

Genetic Implications for Cancer Management: The Changing Landscape of Poly (ADP-ribose) Polymerase Inhibitor Indications in the Treatment of Ovarian Cancer

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