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CHMP recommends EMA approval of polatuzumab vedotin for the treatment of adult patients with R/R DLBCL

Nov 19, 2019

On the 14 thNovember 2019, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)recommended the approval of polatuzumab vedotin, in combination with bendamustine and rituximab (BR), for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are unsuitable for a hematopoietic stem cell transplant. 1 Polatuzumab vedotin is a first-in-class anti-CD79b antibody-drug conjugate, which kills malignant B cells by delivering anti-mitotic monomethyl auristatin E. 2

The combination was approved earlier this year by the U.S. Food and Drug Administration (FDA) for the treatment of patients with DLBCL (read more here).

The CHMP’s positive opinion was based on data from the global phase Ib/II study GO29365 ( NCT02257567) that evaluated the safety, tolerability, and activity of polatuzumab vedotin in combination with BR or obinutuzumab in R/R follicular lymphoma or DLBCL. The polatuzumab vedotin-BR combination achieved a complete response rate of 40% (n= 16/40) compared with 17.5% (n= 7/40) with BR alone, and a median survival of 12.4 months versus4.7 months, respectively. 3,4 

  1. Roche. CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma. Press release; 2019 Nov 15. [Accessed 2019 Nov 15]
  2. Dornan D. et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood. 2009 Sep 24; 114(13):2721–2729. DOI: 10.1182/blood-2009-02-205500
  3. Sehn L.H. et al. Polatuzumab Vedotin (Pola) Plus Bendamustine (B) with Rituximab (R) or Obinutuzumab (G) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Updated Results of a Phase (Ph) Ib/II Study.  Blood. 2018 Nov 29; 132(Supplement 1):1683.  DOI:  10.1182/blood-2018-99-118551
  4. Sehn L.H. et al. Randomized phase 2 trial of polatuzumab vedotin (pola) with bendamustine and rituximab (BR) in relapsed/refractory (r/r) FL and DLBCL.  J Clin Onc. 2018 Jun 01; 36(15-suppl):7507. DOI:  10.1200/JCO.2018.36.15_suppl.7507