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Zanubrutinib plus obinutuzumab receives positive CHMP opinion for the treatment of adult patients with R/R FL
On October 16, 2023, it was announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion for zanubrutinib, a Bruton’s tyrosine kinase inhibitor, plus obinutuzumab for the treatment of adult patients with relapsed/refractory follicular lymphoma who have received at least two prior lines of systemic therapy.1 This recommendation was based on positive data from the pivotal phase II ROSEWOOD trial (NCT03332017).1
ROSEWOOD is an ongoing global, phase II study investigating zanubrutinib plus obinutuzumab compared with obinutuzumab alone in 217 adult patients with relapsed/refractory follicular lymphoma who received at least two prior lines of systemic therapy. At a median follow-up of 20 months, the overall response rate was 69% versus 45.8% in the zanubrutinib plus obinutuzumab and obinutuzumab monotherapy arms, respectively (p = 0.0012); and treatment was well-tolerated.1
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