Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population

Roche announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Roche’s supplemental Biologics License Application (sBLA) for Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) 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 US 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 US to full approval.

Columvi remains under accelerated approval for people with 3L+ DLBCL. Discussions with the FDA are ongoing to confirm the phase III SKYGLO study investigating Columvi in combination with Polivy (polatuzumab vedotin), MabThera/Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone for patients with previously untreated large B-cell lymphoma as the new postmarketing requirement. 

“While we are disappointed with this outcome, we remain confident in the data supporting the value of Columvi for US patients who have relapsed following initial treatment, and its key role as monotherapy in the third-line setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to bringing Columvi to more people living with lymphoma and are actively exploring its potential in additional treatment settings, including as frontline therapy.”

"For patients with this aggressive form of lymphoma, effective treatment after relapse is paramount. The STARGLO study showed that Columvi-GemOx significantly improves overall survival and could have a positive impact for patients earlier in their treatment journey. This regimen is already approved in over 35 countries, which underscores the urgent need it addresses," said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at the Massachusetts General Hospital Cancer Center, and principal investigator of the STARGLO study.