publication date: Mar. 31, 2017

Genentech’s rituximab SC received unanimous ODAC approval recommendation

By Matthew Bin Han Ong

The FDA Oncologic Drugs Advisory Committee March 29 unanimously recommended approval of a lymphoma treatment, to be administered via subcutaneous injection.

ODAC recommended full approval for Genentech’s co-formulation, which combines Rituxan (rituximab), a CD20-directed cytolytic antibody, with hyaluronidase, a protein enzyme that increases the absorption of injected fluids.

At the three-hour meeting, FDA asked for input on the acceptability of Genentech’s development approach—a pharmacokinetic bridging program—to support approval for the rituximab subcutaneous product. In recent years, FDA has been using ODAC sparingly.

The agency’s clinical advisors can be brought together for a variety of reasons, such as verbalizing the rationale for either killing an application or stating publicly that the approvability standard has been tweaked, and—more importantly—provide rationale for setting a precendent.

In this case, the safety and efficacy of Genentech’s rituximab combination was demonstrated not through massive non-inferiority studies, the sort that can easily enroll 1,000 patients, but through modest-sized cohorts—50 or so—who enroll in PK-bridging studies.

Genentech sought to demonstrate that the subcuteneous rituximab combination achieved the same drug conventration levels as rituximab administered intravenously—and it did. No other cancer drug has been approved based on PK-bridging studies.    

Bridging programs utilize … Continue reading Genentech’s rituximab SC received unanimous ODAC approval recommendation

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