The Food and Drug Administration on Wednesday approved Roche’s antibody drug Polivy for patients with a common form of lymphoma who haven’t been previously treated, substantially expanding the medicine’s use.
First cleared in 2019, Polivy is for diffuse large B cell lymphoma, the most common form of non-Hodgkin lymphoma. Previously, its use was limited to patients whose disease had progressed following two other treatments. It is a type of newer drug called an antibody-drug conjugate, which uses an engineered protein to deliver a chemotherapy directly to tumor cells, improving the effectiveness of the chemotherapy and reducing side effects.
In the new setting, physicians must use Polivy alongside a drug combination called R-CHP, which includes another Roche antibody called Rituxan.
Before granting approval, the FDA reviewed data from a trial called POLARIX, in which the Polivy-based combination was compared to a standard-of-care drug therapy called R-CHOP. In that study, 77% patients receiving the Polivy drug combination survived two years without progressing, compared with 70% of those receiving R-CHOP — a relative risk reduction of 27%.
At two years, researchers couldn’t yet detect a significant difference in overall survival between the patients receiving the Polivy combination and those who got R-CHOP. The Polivy combination didn’t result in more side effects than R-CHOP. More people who received Polivy had reduced counts of white blood cells, but that didn't result in increased infection rates or discontinued use of the drug.
“It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,” said Levi Garraway, Roche’s chief medical officer and head of global product development, in a statement. “[Wednesday]’s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.”
The FDA’s decision also converts to full approval Polivy’s accelerated clearance for use following progression on two other drug therapies, which was based on patient remissions.
In March, expert advisers to the FDA voted 11-2 in favor of approving Polivy in this early treatment setting. Still, the advisers noted how the 7 percentage point improvement in progression-free survival was modest, albeit statistically significant. They also noted that Polivy treatment hadn’t yet shown an improvement in overall survival, and appeared to only show a progression benefit in patients with a type of disease called “high-grade” lymphoma.
The FDA approved the drug in both the high-grade patients and a wider group of patients referred to as “not otherwise specified,” for which Polivy’s benefit was less clear.