FDA News

FDA expands approval of Rituxan for two rare forms of vasculitis

The FDA has approved a label update for Genentech’s Rituxan to include information on follow-up treatment for adults with granulomatosis with polyangiitis and microscopic polyangiitis who have achieved disease control with induction treatment, according to a company press release.

“Options for continued treatment in GPA and MPA, chronic autoimmune diseases in which patients experience periods of flares, are currently limited,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan (rituximab) to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment.”

U.S. Food and Drug Administration 
The FDA has approved a label update for Genentech’s Rituxan to include information on follow-up treatment for adults with granulomatosis with polyangiitis and microscopic polyangiitis who have achieved disease control with induction treatment, according to a press release.
Source: FDA

The FDA label update is based on data from the Roche-funded MAINRITSAN study, a randomized, controlled clinical trial conducted by the French Vasculitis Study Group. In that study, researchers used Roche-manufactured, European Union-approved rituximab to determine the efficacy and safety of the rituximab regimen, defined as the E.U.-approved rituximab plus glucocorticoids, compared to azathioprine as follow up treatment. A total of 115 patients — 86 with GPA, 24 with MPA and five with renal-limited ANCA-associated vasculitis — who had achieved disease control after induction of remission with glucocorticoids and cyclophosphamide participated in the trial.

The primary endpoint was the occurrence of major relapse — defined as the reappearance of clinical or laboratory signs of vasculitis that could lead to organ failure or damage, or patient death — through month 28. By month 28, major relapse occurred in 5% of patients treated with the rituximab regimen and in 29% of those who received azathioprine.

The FDA has approved a label update for Genentech’s Rituxan to include information on follow-up treatment for adults with granulomatosis with polyangiitis and microscopic polyangiitis who have achieved disease control with induction treatment, according to a company press release.

“Options for continued treatment in GPA and MPA, chronic autoimmune diseases in which patients experience periods of flares, are currently limited,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “As part of our commitment to support people living with rare diseases, we are pleased to provide updated prescribing information for Rituxan (rituximab) to help physicians make more informed decisions about therapeutic options for patients who have achieved disease control with induction treatment.”

U.S. Food and Drug Administration 
The FDA has approved a label update for Genentech’s Rituxan to include information on follow-up treatment for adults with granulomatosis with polyangiitis and microscopic polyangiitis who have achieved disease control with induction treatment, according to a press release.
Source: FDA

The FDA label update is based on data from the Roche-funded MAINRITSAN study, a randomized, controlled clinical trial conducted by the French Vasculitis Study Group. In that study, researchers used Roche-manufactured, European Union-approved rituximab to determine the efficacy and safety of the rituximab regimen, defined as the E.U.-approved rituximab plus glucocorticoids, compared to azathioprine as follow up treatment. A total of 115 patients — 86 with GPA, 24 with MPA and five with renal-limited ANCA-associated vasculitis — who had achieved disease control after induction of remission with glucocorticoids and cyclophosphamide participated in the trial.

The primary endpoint was the occurrence of major relapse — defined as the reappearance of clinical or laboratory signs of vasculitis that could lead to organ failure or damage, or patient death — through month 28. By month 28, major relapse occurred in 5% of patients treated with the rituximab regimen and in 29% of those who received azathioprine.