FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

The FDA issued a Complete Response Letter (CRL) rejecting Roche/Genentech's application for Columvi (glofitamab-gxbm) combined with gemcitabine and oxaliplatin (GemOx) as a second-line treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in patients ineligible for autologous stem cell transplant1 2 3 4.

Regulators cited insufficient evidence from the phase 3 STARGLO study to support this expanded indication1 2 3 4.

Columvi retains its accelerated approval in the United States for use as a single agent (monotherapy) for DLBCL patients who have received at least two prior systemic therapies (third-line or later)1 2 3 4.

Roche/Genentech is in discussions with the FDA to use the ongoing phase 3 SKYGLO study as a new confirmatory post-marketing trial for Columvi1 2.

Columvi is already approved in over 35 countries for certain DLBCL indications, but the latest FDA decision limits its broader use in earlier lines of therapy in the U.S.1.

Sources:

1. https://www.marketscreener.com/news/roche-fda-rejects-new-indication-for-columvi-ce7c5cded08bf023

2. https://www.investing.com/news/company-news/fda-rejects-genentechs-columvi-for-secondline-lymphoma-treatment-93CH-4142286

3. https://www.oncologynewscentral.com/drugs/info/fda-rejects-glofitamab-for-diffuse-large-b-cell-lymphoma-indication

4. https://www.ajmc.com/view/fda-delivers-a-crl-to-glofitamab-for-relapsed-refractory-dlbcl

Sources:

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