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Date: 2017-06-02

Type of information: Granting of a Market Authorisation in the EU

Product name: Opdivo®

Compound: nivolumab

Therapeutic area: Cancer - Oncology

Action mechanism:

  • monoclonal antibody/immune chekcpoint inhibitor. Nivolumab is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. By blocking this pathway, nivolumab enables the immune system to resume its ability to recognize, attack and destroy cancer cells.
  • Opdivo® as a single agent is already indicated for the treatment of :
  • • patients with BRAF V600 mutation-positive unresectable or metastatic melanoma and for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
  • It is also indicated, in combination with Yervoy® (ipilimumab), for the treatment of patients with unresectable or metastatic melanoma.
  • • patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo®.
  • • patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
  • • adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation  and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous hematopoietic stem cell transplantation.
  • • patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
  • • patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Company: BMS (USA - NY)

Disease: locally advanced unresectable or metastatic urothelial carcinoma (mUC)

Latest news:

  • • On June 2, 2017, BMS announced that the European Commission has approved Opdivo® (nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. This decision makes Opdivo® the first Immuno-Oncology agent approved in the European Union for the treatment of patients with this common type of bladder cancer.
  • The approval was based on results from CheckMate -275, a Phase 2, open-label, single-arm, multicenter study evaluating Opdivo® in patients with locally advanced or mUC who have disease progression during or following treatment with a platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In this study, 270 patients received Opdivo® 3 mg/kg administered intravenously every two weeks until disease progression or unacceptable toxicity. The primary endpoint of the trial was objective response rate (ORR). Secondary endpoints included progression free survival (PFS) and overall survival (OS). In the trial, 20.0% (95% CI: 15.4, 25.3; 54/270) of patients responded to treatment with Opdivo®. The percentage of patients with a complete response was 3.0% (8/270) and the percentage of patients with a partial response was 17% (46/270).
  • Half of the overall patient population (46%) in CheckMate -275 had a tumor PD-L1 expression of ?1% and efficacy was observed across tumor PD-L1 expressors and non-expressors. The response rate was 25% in patients with tumor PD-L1 expression ?1% (95% CI: 17.7, 33.6) and 15.8% (95% CI: 10.3, 22.7) in those with tumor PD-L1 expression <1%. In all treated patients, the median PFS was 2.0 months, the 12-month OS rate was 41% (95% CI: 34.8, 47.1) and the median OS was 8.6 months (95% CI: 6.1, 11.3).
  • Among the 270 patients who received Opdivo® in CheckMate -275, 17.8% experienced a grade 3 or 4 treatment-related adverse event (AE). The most frequently reported treatment-related AEs of any grade included fatigue (16.7%), pruritis (9.3%), diarrhea (8.9%), decreased appetite (8.1%), hypothyroidism (7.8%), nausea (7.0%), asthenia (5.9%), rash (5.9%) and pyrexia (5.6%). The most frequent treatment-related grade 3-4 AEs were fatigue (1.9%), diarrhea (1.9%), asthenia (1.5%) and rash (1.1%). Overall, 4.8% of patients discontinued therapy due to treatment-related AEs of any grade, and 3.0% discontinued therapy due to grade 3-4 treatment-related AEs. Treatment-related death occurred in four patients due to pneumonitis or cardiovascular failure.
         

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2017-06-02

Favourable opinion UE: 2017-04-21

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes