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Roche is pleased to share the news of the FDA approval of POLIVY in combination with R-CHP for adult patients with previously-treated DLBCL. Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of DLBCL.
The FDA approval is based on the POLARIX study in which it was shown that POLIVY + R-CHP, compared to R-CHOP, was able to reduce the risk of disease progression, recurrence or death by 27%, while maintaining a similar safety profile.
This approval, as well as the prior approval of Pola-R-CHP by the European Commission, brings the total approvals of POLIVY in 1L DLBCL to 70 countries.
In addition, POLIVY is recommended in 1L DLBCL by the NCCN and by other national guidelines including in Germany, and has received NICE recommendation for use in the UK’s National Health System.
“If we have an intervention that we can use in the frontline setting that reduces the chance of you relapsing, then I think it is really important that we use this in our treatment algorithm.”
Prof. Andrew Davies
Watch a short video of our expert interview with international senior hematologists Prof. Davies, Prof. Collins and Dr. Osborne regarding their thoughts on the need for less subsequent treatments with POLIVY + R-CHP compared to R-CHOP:
A more noticeable effect was shown in high-risk population subgroups including IPI 3-5: 2-year △PFS: 10.1% and COO-ABC: 2-year △PFS 25.1%
“We want to stop any progression events for our patients with high grade lymphoma because second line and subsequent treatments is tough and often the outcomes are poor.”
Dr. Wendy Osborn
Dr. Osborne share her thoughts on the PFS & OS results from the POLARIX trial:
Including Pola-R-CHP in first-line DLBCL treatment has the potential to lessen the physical, emotional and financial burden on patients, their relatives, and healthcare systems by reducing disease progression and the need for advanced treatments.
“Cure, it is all about cure. Reducing relapses and leading to long term patient benefit and I think it is what we see with the results of the POLARIX trial.”
Prof. Graham Collins
Prof. Collins and Dr. Osborne on the benefits they foresee of using POLIVY + R-CHP in the first-line setting:
If you have any further questions, please do not hesitate to consult your contact person.