SOUTH SAN FRANCISCO (dpa-AFX) - Roche Holding AG (RHHBY) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a subcutaneous (SC) formulation of Lunsumio for the treatment of adults with follicular lymphoma.
The CHMP opinion is based on the Phase II GO29781 study, in which subcutaneous Lunsumio demonstrated pharmacokinetic non-inferiority compared to intravenous administration, with no unexpected safety signals.
The company said that data from the Phase II GO29781 study have been submitted to health authorities worldwide, including the U.S. Food and Drug Administration(FDA), for approval consideration.
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