FDA’s Cancer Advisory Committee to evaluate safety of P13K inhibitors

pharmafile | April 21, 2022 | News story | Business Services  

The FDA’s Oncologic Drugs Advisory Committee is holding a meeting today to discuss safety findings across the entire class of P13K inhibitors for haematological cancers.

The FDA is asking the advisory committee to make a recommendation on whether future approvals for this class of drug should be based on randomised data instead of single-arm clinical trials.

As it stands, there are four P13K inhibitors approved by the FDA under this context. These include Gilead Sciences’ Zydelig (idelalisib), Bayer’s copanlisib, Secura Bio’s develisib, and TG Therapeutics’ umbralisib.

Gilead’s Zydelig is approved for relapsed chronic lymphocytic leukaemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities. All of these drugs have demonstrated durable overall response rates or improvements in progression-free survival, but the side effects have proved to be serious and potentially deadly.

Richard Pazdur, director of the FDA Oncology Center of Excellence, told The Cancer Letter, “This is a forward-thinking discussion of how these products should be developed, based on what has been observed so far, and will focus on four major issues.”

As the FDA’s Richard Pazdur, Nicholas Richardson, Yvette Kasamon and Nicole Gormley of the Division of Hematologic Malignancies 2 wrote in Lancet Oncology, “The development programs of the PI3K inhibitors in haematological malignancies highlight challenges associated with the current paradigm of using overall response rates in single-arm trials to support accelerated approvals. Generally, limited dose-exploration studies were conducted before choosing maximum or near-maximum tolerated doses for subsequent single-arm trials for accelerated approval.”

Lina Adams

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