Genentech announced that the FDA issued a Complete Response Letter regarding its request to expand the use of Columvi, in combination with gemcitabine and oxaliplatin, as a second-line treatment for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The agency found that data from the Phase III STARGLO study did not provide enough evidence to support this additional use. Columvi will continue to be available in the U.S. under its current approval as a third-line or later treatment for DLBCL. Genentech is currently in discussions with the FDA to evaluate whether the ongoing Phase III SKYGLO trial—which studies Columvi with Polivy, Rituxan, and chemotherapy in newly diagnosed patients—could meet the agency’s requirements for further approval.

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“Even though we are disappointed with this outcome, we still believe in the data that show Columvi’s value for U.S. patients who relapse after first treatment, and its important role as a single treatment in third-line therapy,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. Jeremy Abramson, M.D., director at Massachusetts General Hospital Cancer Center and principal investigator for the STARGLO trial, added, “For patients with this aggressive type of lymphoma, getting successful treatment after relapse is very important. The STARGLO study showed that Columvi-GemOx greatly improves overall survival and might also help patients earlier in their treatment journey.”

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While the FDA has not yet approved the Columvi-GemOx combination in the U.S., the STARGLO study demonstrated a 41% reduction in the risk of death, which has led to approval of the treatment in over 35 countries. Genentech remains committed to working with U.S. health authorities to explore new treatment paths and expand access to potentially life-extending therapies for people living with DLBCL.

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