Genetech: STARGLO data does not provide sufficient evidence for DLBCL indication

Genentech announced that the U.S. Food and Drug Administration issued a Complete Response Letter for Genentech’s supplemental Biologics License Application for Columvi n combination with gemcitabine and oxaliplatin for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant. Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the U.S. patient population. STARGLO was also intended as a postmarketing confirmatory study to convert the accelerated approval of Columvi in third-line or later DLBCL in the U.S. to full approval. Columvi remains under accelerated approval for people with third-line or later DLBCL. Discussions with the FDA are ongoing to confirm the Phase III SKYGLO study investigating Columvi in combination with Polivy, Rituxan, cyclophosphamide, doxorubicin and prednisone for patients with previously untreated large B-cell lymphoma as the new postmarketing requirement. Based on the STARGLO data, this Columvi combination is approved in more than 35 countries, including in the EU, and recommended in clinical practice guidelines including the U.S. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Data has been submitted to other health authorities around the world for approval consideration. Columvi monotherapy has been approved for use in R/R DLBCL after two or more prior lines of therapy in more than 60 countries worldwide.