Marketing authorisation study:

1. GO29365 (NCT02257567)

Indication: Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Phase: Ib/II

Summary: Multi-centre, open-label study to assess the efficacy and safety of Polivy® in combination with bendamustine (B) and rituximab (R) in comparison to BR alone in patients with pre-treated DLBCL who are not eligible for a haematopoietic stem cell transplant.

Sponsor: F. Hoffmann-La Roche AG

Publication of the results of clinical trials
Publication of the results of clinical trials The information given above and the links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorisation for Polivy. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorisation by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.

POLIVY® (polatuzumab vedotin), powder for concentrate for solution for infusion (injection vials containing 30 mg and 140 mg polatuzumab vedotin)

Swissmedic marketing authorisation number: 67165
Swissmedic marketing authorisation date: 15 June 2021