Subcutaneous Rituximab Seems Headed For US FDA Advisory Panel OK
Genentech used pharmacokinetic bridging studies for new route of administration, which uses the enzyme hyaluronidase and is strongly preferred by patients over the IV; firm is seeking indications for follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.
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Patient Experience Data May Require Separate Label, Genentech Suggests
US labeling for Genentech's Rituxan Hycela appears to have broken new ground with a 'Patient Experience' section describing summary data from a patient preference study; however, the company's global head of outcomes research says large volumes of patient-centric data would be difficult to reflect within the current labeling framework.
Keeping Track: Clarus, Agile and Sunovion Look To Bounce Back From CRLs; FDA To Review Rituximab Biosimilar
The latest drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: Cardio, Antibiotic Approvals Put FDA Over Last Year's Novel Drug Count
The latest drug development news and US FDA highlights from our Performance Tracker.