The Roche Group company Genentech said on Friday that the U.S. FDA has denied its request to increase the usage of its cancer medication Columvi® (glofitamab-gxbm). For patients with a particular kind of aggressive blood cancer, the business had applied for approval to use the medication in conjunction with chemotherapy.
The FDA essentially declined to approve Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) when it issued a Complete Response Letter (CRL) for the supplemental biologics license application (sBLA).
Genentech was expecting to make the Columvi combination available to U.S. patients who had relapsed after first treatment, but the decision marks a setback. Data from the Phase III STARGLO research, which showed a 41% decrease in the risk of death when taking the Columvi combo, backed the sBLA.
While we are disappointed with this outcome, we remain confident in the data supporting the value of Columvi for U.S. patients who have relapsed following initial treatment, and its key role as monotherapy in the third-line setting,
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.
Levi Garraway
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More than 35 nations, including the European Union, have already authorized the use of the Columvi and GemOx combination. In the US, Columvi’s fast approval for treating adult patients with specific forms of DLBCL following two or more lines of systemic therapy is still in effect. In order to turn this expedited permission into a full approval, the STARGLO research was also designed to act as a confirmatory trial. The business has not yet disclosed what it plans to do regarding the sBLA.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
