In March the FDA’s expert advisers voted 11 to 2 in favor of approving Roche’s antibody drug Polivy to treat lymphoma patients. According to an article in BiopharmaDive, the decision also moves the drug from accelerated to full approval.
Polivy, a treatment for a form of non-Hodgkin lymphoma called diffuse large B cell lymphoma, received its first clearance in 2019. Initially, the drug was used to treat patients after disease progression and two previous treatments. For the current trial, only patients who have not been treated previously will be enrolled. The approval expands Polivy’s range of treatment.
Polivy is a form of antibody-drug conjugate that collectively are one of the fastest-growing anticancer drugs. The drug uses a protein that is engineered to deliver targeted chemotherapy.
The new form of therapy uses Polivy and the drug combination R-CHP alongside Roche’s Rituxan.
Prior to the FDA’s approval, the Agency compared data from the POLARIX trial. In this trial, the Polivy combination was matched against R-CHOP which had been the standard of care.
In POLARIX 77% of patients who received the Polivy combination survived over a two-year period with no progression. These results were compared to 70% of patients who received R-CHOP.
The Two-Year Mark
Yet at the two-year mark, the two groups were still in close proximity to each other with no significant difference in overall survival. It appeared that the drug only showed progression benefits in patients who had “high-grade” (aggressive) lymphoma.
Still, the advisers acknowledged that although the 7% progression-free survival may be modest, it was still statistically meaningful.
But on a positive note, Polivy was equal to R-CHOP with respect to side effects. Also, a larger reduction in white blood counts was discovered in the Polivy group yet this did not bring about increased rates of infection or discontinuation of Polivy.
Time for a Change
Roche’s CMO Levi Garraway commented that there have been no approved treatments for newly diagnosed individuals with diffuse large B-Cell lymphoma in the past twenty years.
He added that the FDA’s recent decision to approve the Polivy combination offers a critical treatment option that may benefit others with this highly aggressive lymphoma.