publication date: Jul. 20, 2018

Pilot programs aim to revamp cancer drug approval process—from completion of trial to ODAC presentation

By Paul Goldberg

FDA is revamping the gearing in the machinery of approval of cancer drugs, making it possible to initiate regulatory review immediately after the clinical trials datasets are locked.

While the pilot programs—called Real-Time Oncology Review and Assessment Aid—are introduced in supplemental new drug application, the goal would be to develop them for use in new drug applications.

If these pilot programs work, they will guide the restructuring of the entire cancer drug approval process at FDA, starting at the moment when the drug sponsor finalizes—or locks—the dataset all the way through presentations to the FDA Oncologic Drugs Advisory Committee.

On July 18, the Real-Time Oncology Review and Assessment Aid resulted in the first approval—the Novartis drug Kisqali (ribociclib).

The ribociclib approval timeline, reconstructed by The Cancer Letter, follows:

The new process created “a continuous, transparent, very promising dialogue between the agency and us on a continuing basis,” said Samit Hirawat, an execitive vice president and head of Global Oncology at Novartis.

Novartis and FDA worked in “a continuous dialogue on a daily basis,” Hirawat said. This way for doing business “allows the agency or us to pick up the … Continue reading Pilot programs aim to revamp cancer drug approval process—from completion of trial to ODAC presentation

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