The ODAC cited concerns with patient populations in clinical trials used to support the proposed expansion. Johnson & Johnson fared better, with the FDA’s cancer advisors voting to recommend Darzalex in patients with a certain type of multiple myeloma.
The FDA’s Oncologic Drugs Advisory Committee voted overwhelmingly against Genentech’s bid to expand the use of its bispecific antibody, Columvi, combined with gemcitabine and oxaliplatin, to transplant-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma.
With an 8–1 majority against on Tuesday, the FDA’s independent experts raised concerns about the applicability of Genentech’s Phase III STARGLO study, which it is using to back Columvi’s proposed expansion to the broader U.S. population. In particular, the panelists noted that Asian patients comprised half of STARGLO’s intention-to-treat population. Only 25 patients were enrolled in North America.
In its presentation, the FDA similarly flagged this as an issue, noting that there are several factors that could affect the applicability of foreign data to U.S. patients, such as differences in diet, environmental exposures and genetic polymorphisms between these patient populations
In explaining his no vote, Ravi Madan, head of Prostate Cancer Clinical Research at the National Cancer Institute, said that while “therapeutic development in oncology is an increasingly global operation,” drug sponsors need to make “deliberate decisions” to ensure their data “does apply to the U.S. population.”
“Even beyond today’s discussion, this issue is further accentuated when standards of care or practice patterns in the U.S. than other places around the world,” he added.
Columvi is a bispecific antibody that targets the CD20 and CD3 proteins. The biologic won the FDA’s approval in June 2023 for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who had undergone at least two prior lines of systemic therapy.
Genentech, a Roche subsidiary, is seeking to expand its use into R/R DLBCL patients who cannot undergo autologous stem cell transplantation, a patient population that has an “urgent need for effective, immediately available therapies,” the pharma said in a news release on Tuesday.
During the afternoon session of the same advisory committee meeting, the ODAC gave its backing to Johnson & Johnson’s Darzalex Faspro, an anti-CD38 antibody already approved for a handful of multiple myeloma indications. The pharma is proposing to expand its use to adult patients with high-risk smoldering multiple myeloma.
The FDA’s experts voted 6–2, finding Darzalex Faspro’s benefit-risk profile as a single-agent therapy to be favorable in this patient population.
