EMA-recommendations-primeoncology_2017

EMA Recommends Approval of Four New Anticancer Agents in September

On 14 September 2017, the European Medicines Agency (EMA) issued positive opinions for the approval of four new treatment options for oncology and hematology, including a biosimilar of trastuzumab for breast cancer, padeliporfin for vascular-targeted photodynamic therapy (VTP) of low-risk prostate cancer, maintenance niraparib for platinum-sensitive relapsed ovarian cancer, and nilotinib for pediatric patients.

  • Green Light for First Trastuzumab Biosimilar. Ontruzant® (Samsung Bioepis UK Limited), a biosimilar of trastuzumab, was recommended for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early and metastatic breast cancer and HER2-positive metastatic gastric cancer. This is the first biosimilar of trastuzumab to be approved in Europe. It has been shown to be highly similar to its reference product, Herceptin®, in a series of quality, safety, and efficacy studies, including a phase I pharmacokinetics study in healthy volunteers and a phase III trial in patients with early or locally advanced HER2-positive breast cancer.
  • New Focal Therapy for Localized Prostate Cancer. The EMA recommended approval for padeliporfin (Tookad®, STEBA Biotech), a sensitizer used as part of focal vascular-targeted photodynamic therapy (VTP), for patients with previously untreated, unilateral, low-risk prostate cancer. This recommendation was based on results from a phase III trial in which padeliporfin VTP resulted in a doubling in time to progression compared to active surveillance (28.3 months vs 14.1 months; HR 0.34, P<.0001) in patients with low-risk, previously untreated prostate cancer.
  • PARP Inhibitor Recommended for Maintenance Therapy in Ovarian Cancer. The EMA recommended approval of niraparib (Zejula®, TESARO UK Limited), a poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor, for maintenance therapy in patients with platinum-sensitive, relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who following platinum-based chemotherapy. This decision was based on results from the randomized, phase III NOVA trial, in which niraparib maintenance was shown to significantly lengthen progression-free survival compared to placebo in patients regardless of BRCA mutation or homologous recombination deficiency status. Niraparib has been available in the US since March 2017.
  • Nilotinib Indication Expanded to Include Pediatric CML. The EMA recommended expanding the indication of nilotinib (Tasigna®, Novartis) to include pediatric patients with newly diagnosed, Philadelphia chromosome (Ph)-positive chronic-phase chronic myelogenous leukemia (CML), and pediatric patients with Ph-positive chronic-phase CML who are resistant or intolerant to imatinib.

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