publication date: Oct. 5, 2018

Drugs & Targets

FDA releases draft guidance on master protocol studies

FDA has published a draft guidance titled “Master Protocols–Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics.”

Because of the growing interest in master protocol trial designs, which are complex due to concurrent evaluation of multiple drugs and/or disease populations within a single trial, as well as their potential regulatory impact, it is important that the trials are well-designed and well-conducted to ensure patient safety and to obtain quality data that may support drug approval.

This guidance provides advice to pharmaceutical sponsors, the academic community, institutional review boards, and the public on aspects of master protocol designs and trial conduct that pose additional regulatory consideration, such as biomarker development and statistical analysis considerations, and provides advice on the information that sponsors should submit to FDA and how sponsors can interact with FDA to facilitate efficient review.

Sponsors who anticipate developing drugs under a master protocol are strongly encouraged to communicate with FDA early in the development program to obtain feedback on the design of the protocol before submitting an investigational new drug.

Please refer to the guidance for more details.


FDA approves Kyprolis with dexamethasone for relapsed or refractory multiple myeloma

FDA has approved the supplemental New Drug Application to expand the prescribing information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma.

The drug is sponsored by Amgen Inc.

The approval is based on data from the phase III A.R.R.O.W. trial, which demonstrated that Kyprolis administered once-weekly … Continue reading FDA releases draft guidance on master protocol studies

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