FDA rejects Genentec's cancer drug label expansion

Genentech, part of the Roche Group (OTCQX:RHHBY) (OTCQX:RHHBF) (OTCPK:RHHVF), announced that the U.S. FDA has rejected its request to expand the use of its cancer drug Columvi.

The company had applied for approval to use Columvi in combination with chemotherapy for people with relapsed or difficult-to-treat diffuse large B-cell lymphoma (DLBCL) who aren't eligible for a stem cell transplant.

The FDA issued a complete response letter (CRL), when the agency found that the supporting study, called STARGLO, did not provide enough evidence for approval in this earlier treatment setting. 

This study was also meant to help convert Columvi’s accelerated approval, currently granted for use in patients who've already tried at least two other treatments, into a full approval in the U.S.

Columvi remains available under accelerated approval for patients with third-line or later DLBCL. Genentech is now in talks with the FDA to use a different study, called SKYGLO, as the new confirmatory trial. 

Columvi is already approved in over 60 countries for patients with relapsed or refractory DLBCL who have received two or more previous treatments.