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# Genentech Gets ‘Breakthrough’ Status for Rituxan New Indication
- URL: https://www.fdaweb.com/genentech-gets-breakthrough-status-for-rituxan-new-indication/
- Published: 2017-03-24T12:00:00.000Z
- Updated: 2026-09-14T22:13:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138288

FDA has granted Genentech a breakthrough therapy designation for Rituxan (rituximab) and its use for treating pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. The company is currently enrolling patients in a Phase 3 study (PEMPHIX, NCT02383589), a randomized, double-blind, double-dummy, active-comparator, parallel-arm multicenter study evaluating Rituxan compared with mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent). Rituxan is currently approved for treating rheumatoid arthritis, granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis.