Roche scores FDA approval for Polivy combo in diffuse large B-cell lymphoma
pharmafile | June 11, 2019 | News story | Manufacturing and Production, Sales and Marketing | Polivy, Roche, lymphoma, pharma
Roche is celebrating the decision taken by the FDA to approve its anti-CD79b antibody-drug conjugate Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and Rituxan (rituximab) (BR) as a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in who have received at least two prior therapies.
The drug regimen was approved after being granted Accelerated Approval from the FDA. The US regulator’s decision was taken based on data derived from 80 patients ineligible for haematopoietic stem cell transplant.
It was found that 40% of patients receiving the Polivy regimen achieved complete response compared to just 18% with BR alone, while 45% achieved an objective response compared to 18%.
Of this number which achieved at least a partial response, 64% reported a duration of response of at least six months, an achievement only matched by 30% of patients in the those receiving BR alone. 48% of patients receiving Polivy plus BR saw a duration of response lasting at least a year, compared to 20% with BR alone.
“Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens,” said Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”
While the regulatory decision is significant for the company and for lymphoma patients, Roche noted that “continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.”
Matt Fellows
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