FDA rejects Genentech's Columvi combination for lymphoma treatment

The U.S. Food and Drug Administration issued a Complete Response Letter rejecting Genentech's supplemental application for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin for treating relapsed or refractory diffuse large B-cell lymphoma patients who are not candidates for stem cell transplant.

The FDA determined that data from the STARGLO study do not provide sufficient evidence to support the proposed second-line indication in the U.S. patient population, according to a statement from Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY).

Columvi maintains its accelerated approval for third-line or later treatment of the aggressive blood cancer. The STARGLO study was intended to convert this accelerated approval to full approval while supporting the new second-line indication.

The Phase III STARGLO study showed a 41% reduction in the risk of death with a hazard ratio of 0.59 for patients treated with the Columvi combination compared to the control group. The combination therapy is approved in more than 35 countries, including the European Union.

Genentech is discussing with the FDA to confirm the Phase III SKYGLO study as the new postmarketing requirement. This study investigates Columvi in combination with Polivy, Rituxan, cyclophosphamide, doxorubicin and prednisone for previously untreated large B-cell lymphoma patients.

Diffuse large B-cell lymphoma affects approximately 160,000 people worldwide annually. While generally responsive to initial treatment, up to 40% of patients experience relapse or refractory disease, with limited treatment options available.

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