Outside advisers to the Food and Drug Administration have backed expanding use of Roche’s drug Polivy, voting 11-2 Thursday in favor of approving it for patients newly diagnosed with the most common type of non-Hodgkin lymphoma.
If the FDA follows the advisory committee’s advice, as it usually does, Polivy would be cleared for first-line use in patients with diffuse large B cell lymphoma alongside a commonly used regimen called R-CHOP that has been the standard of care since 2006. An OK from the regulator would also convert the conditional nod Polivy received as a third-line treatment in 2019 to a full approval.
The positive vote was issued despite doubts from FDA scientists. In presenting data from Polivy’s key trial, POLARIX, which compared the Polivy-based regimen to R-CHOP, agency reviewers pointed to the lack of a survival benefit and a modest, although statistically significant, 7% delay in tumor progression compared to R-CHOP after two years.
FDA scientists also said the drug’s benefits varied by subgroup. In the largest group of DLBCL patients enrolled in the study, those called “not otherwise specified,” overall survival was numerically better in those who received R-CHOP at all time points measured. Results favored the Polivy regimen, though, for those with a rarer and more aggressive type of DLBCL called “high-grade,” the reviewers said.
“We believe the clinical benefit demonstrated in the POLARIX study may improve outcomes for many people with newly diagnosed DLBCL and look forward to continued collaboration with the FDA to make this treatment option available in the U.S.,” said Roche Chief Medical Officer Levi Garraway, in a statement.
Polivy is what’s known as antibody drug conjugate, or ADC, which combines a cancer-killing toxin with a targeting antibody. ADCs are meant to be more precise than chemotherapies, delivering a more direct blow to diseased cells.
Unlike R-CHOP, the Polivy-based regimen doesn’t include vincristine, a chemotherapy that is linked to significant nervous system toxicity.
More than 60 countries have already approved Polivy for newly diagnosed patients, and cancer doctors have also included it in their treatment guidelines for first-line DLBCL, Roche said. The FDA is expected to make its decision by April 2.