In a boost to Rituxan franchise, Roche nabs quick approval for polatuzumab vedotin
Roche’s latest antibody-drug conjugate has crossed the FDA finish line, gaining an accelerated approval a full two months ahead of schedule.
Polivy, or polatuzumab vedotin, is a first-in-class drug targeting CD79b — a protein prominent in B-cell non-Hodgkin lymphoma. It will now be marketed for diffuse large B-cell lymphoma as part of a regimen that also includes the chemotherapy bendamustine and a version of rituximab (Rituxan).
The association with an aging blockbuster product — Rituxan racked up $6.82 billion (6.75 billion CHF) in global sales in 2018 — is reminiscent of Kadcyla, Roche’s first ADC. A HER2 targeting treatment for metastatic breast cancer, Kadcyla comprises the best-selling Herceptin (trastuzumab), which both attacks and binds to HER2-positive cancer cells, allowing the chemo agent to be released inside.
While Rituxan plus chemo can be given as an initial treatment, the Polivy triplet will fill the gap for relapsed or refractory cases. Of the 18,000 patients diagnosed with DLBCL in the US each year, it’s estimated that 30% to 40% would relapse despite the possibility of a cure.
Polivy plus BR have previously demonstrated an overall survival benefit in a study of 80 heavily pre-treated patients, achieving median OS of 12.4 months compared to 4.7 months on BR alone. The complete response rates were 40% and 18% in the drug and control arms, respectively.
Those results earned the drug — made with ADC tech from Seattle Genetics — a priority review at the FDA in addition to breakthrough and orphan designations.
Roche’s Genentech is following up with a range of studies involving combos with its top cancer therapies.
“Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked,” added Richard Pazdur, director of FDA’s Oncology Center of Excellence.
Image Source: Richard Pazdur, AACR