EMA Issues 4 Positive Opinions

EMA Issues Positive Opinions for Four Cancer Drugs in April

On 21 April 2017, the European Medicines Agency (EMA) announced positive opinions for the approval or change in marketing authorization for four agents for the treatment of cancer, including two rituximab biosimilars. Of note, no rituximab biosimilars have been approved in the United States.

  • Two rituximab biosimilars (Rixathon and Riximyo, Sandoz) received positive EMA opinions for approval in several indications for which rituximab (MabThera®, Roche) is currently used. Rixathon’s indications will include non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis, and microscopic polyangiitis, while Riximyo will be approved for all the of these except CLL. These agents were found to be comparable to the originator MabThera® in terms of quality, safety, and efficacy across a stepwise comparability program that included a pharmacokinetic/pharmacodynamics trial in RA (ASSIST-RA) and a phase III confirmatory safety and efficacy trial in follicular lymphoma (ASSIST-FL).
  • The EMA adopted a positive opinion recommending approval of the anti-CD22 antibody inotuzumab ozogamicin (BESPONSA®, Pfizer Limited) for use as monotherapy for treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Patients with Philadelphia-chromosome positive (Ph+) ALL should have received treatment with at least one prior tyrosine kinase inhibitor (TKI). The recommendation for approval is based on results from the phase III INO-VATE 1022 trial in which treatment with inotuzumab ozogamicin resulted in significantly higher rate of complete remission (80.7% vs 29.4%; P<.001) and longer progression-free survival and overall survival compared to standard chemotherapy. Veno-occlusive liver disease was a major adverse event associated with inotuzumab ozogamicin.
  • The EMA also recommended extending the indication of the programmed death receptor 1 (PD-1) inhibiting antibody nivolumab (Opdivo®, Bristol-Myers Squibb) to include treatment of patients with advanced urothelial carcinoma who have failed prior platinum-containing therapy. This recommendation is based on tumor response rates and duration of responses demonstrated in the phase II CheckMate-275 trial. Nivolumab is the first immunotherapy to be approved in the second-line setting for bladder cancer in Europe. In contrast, in the United States, in addition to nivolumab the PD-L1 inhibitors atezolizumab, durvalumab, and avelumab are approved for this indication.

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