The FDA approved a the use of a drug combination that represents the first approved therapy in roughly 20 years for patients newly-diagnosed with diffuse large B-cell lymphoma, the non-Hodgkins lymphoma most prevalent in the U.S.
The drug Polivy in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) was approved on Wednesday, The combination had been approved in 2019 for use but only for patients who had undergone two prior therapies.
“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 Dr. Levi Garraway, chief medical officer and head of global product development for Genentech, which manufactures Polivy. “Today’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.”
A study found that roughly 28 months after the combination was administered, a 27% reduction in the risk of disease production or death for patients occurred compared to patients who received standard of care.
“The FDA’s decision gives newly diagnosed patients with this aggressive form of lymphoma their first new treatment option in nearly two decades,” Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia & Lymphoma Society, stated. “One of our major goals at LLS is to support science that moves us toward less toxic, and more effective treatment options, and this drug combination is a step in that direction.”
“While this new drug is a valuable addition for some patients, we need to keep pressing forward to find even better options for DLBCL and every type of blood cancer,” Greenberger added. “But advances like polatuzumab are important, not just for today’s patients, but because science builds on itself, helping us to learn more about effective use of target drugs and harnessing the immune system to help tomorrow’s patients do even better.”
“I believe this gain in progression-free survival is clinically meaningful for patients, and also leads to a reduction in the need for subsequent therapy,” Grzegorz Nowakowski, MD, of the Mayo Clinic Comprehensive Cancer Center in Rochester, Minnesota, said.