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EMA Greenlights Four Drugs for Bladder and Other Cancers

EMA Greenlights Four Drugs for Bladder and Other Cancers

At its June 27 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorizations for four cancer therapies. 


The CHMP endorsed the approval of Balversa (erdafitinib, Janssen-Cilag International N.V.), intended for the treatment of urothelial carcinoma, a type of cancer affecting the bladder and urinary system.

As a monotherapy, Balversa is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 genetic alterations. These patients must have previously received at least one line of therapy containing a programmed death receptor 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the unresectable or metastatic treatment setting.

Urothelial carcinoma is the most common form of bladder cancer, the ninth most frequently diagnosed cancer worldwide. In 2022, there were approximately 614,000 new cases of bladder cancer and 220,000 deaths globally. 

The highest incidence rates in both men and women are found in Southern Europe. Greece had 5800 new cases and 1537 deaths in 2018. Spain has the highest incidence rate in men globally. Since the 1990s, bladder cancer incidence trends have diverged by sex, with rates decreasing or stabilizing in men but increasing among women in certain European countries. 

The CHMP recommendation is based on data from cohort 1 of the phase 3 THOR trial, which compared erdafitinib with standard-of-care chemotherapy (investigator’s choice of docetaxel or vinflunine). Cohort 1 included 266 adults with advanced urothelial cancer harboring selected FGFR3 alterations. 

All patients had disease progression after one or two prior treatments, at least one of which included a PD-1 or PD-L1 inhibitor. The major efficacy endpoints were overall survival, progression free survival, and objective response rate (ORR).

Treatment with erdafitinib reduced the risk for death by 36% compared with chemotherapy (hazard ratio [HR], 0.64; P = .005). Median overall survival was 12.1 months in the erdafitinib arm vs 7.8 months in the chemotherapy arm. Median progression-free survival was 5.6 months in the erdafitinib arm vs 2.7 months in the chemotherapy arm (HR, 0.58; P = .0002). ORR was 35.3% with erdafitinib compared with 8.5% with chemotherapy.

Balversa will be available as 3-mg, 4-mg, and 5-mg film-coated tablets. Erdafitinib, the active substance in Balversa, is an antineoplastic protein kinase inhibitor that suppresses fibroblast growth factor receptor (FGFR) tyrosine kinases. Deregulation of FGFR3 signaling is implicated in the pathogenesis of urothelial cancer, and FGFR inhibition has demonstrated antitumor activity in FGFR-expressing cells.


The committee adopted a positive opinion for Ordspono (odronextamab, Regeneron Ireland Designated Activity Company), indicated as a monotherapy for the treatment of adult patients with: 

  • Relapsed or refractory follicular lymphoma (rrFL) after two or more lines of systemic therapy
  • Relapsed or refractory diffuse large B‑cell lymphoma (rrDLBCL)after two or more lines of systemic therapy

The approval recommendation is based on phase 2 trials (NCT02290951, NCT03888105), which demonstrated high ORRs in patients with rrFL and rrDLBCL.

In the DLBCL cohort, a 49% ORR was achieved in heavily pretreated patients who had not received chimeric antigen receptor T-cell therapy. A total of 31% achieved a complete response. 

The FL cohort showed an 82% response rate in patients with grades I-IIIA disease, with 75% of the overall population achieving a complete response.

Ordspono will be available as a 2-mg, 80-mg, and 320-mg concentrate for solution for infusion. The active substance of Ordspono is odronextamab, a bispecific antibody that targets CD20‑expressing B cells and CD3-expressing T cells. By binding to both, it induces T‑cell activation and generates a polyclonal cytotoxic T‑cell response, leading to the lysis of malignant B cells. 


The panel also adopted positive opinions for two generic cancer medicines.

Enzalutamide Viatris (enzalutamide) is indicated for the treatment of adult men with prostate cancer in several scenarios:

  • As monotherapy or with androgen deprivation therapy for high-risk biochemical recurrent nonmetastatic hormone-sensitive prostate cancer in men unsuitable for salvage-radiotherapy
  • In combination with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer
  • For high-risk nonmetastatic castration-resistant prostate cancer
  • For metastatic CRPC in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy, where chemotherapy is not yet indicated
  • For metastatic CRPC in men whose disease has progressed on or after docetaxel therapy

Enzalutamide Viatris is a generic version of Xtandi, authorized in the European Union since June 2013. Studies have confirmed the satisfactory quality and bioequivalence of Enzalutamide Viatris to Xtandi.

Enzalutamide Viatris will be available as 40-mg and 80-mg film-coated tablets. The active substance of Enzalutamide Viatris is enzalutamide, a hormone antagonist that blocks multiple steps in the androgen receptor–signaling pathway.

Nilotinib Accord (nilotinib) is indicated for the treatment of Philadelphia chromosome–positive chronic myelogenous leukemia (CML).

It is used in adult and pediatric patients with newly diagnosed CML in the chronic phase, adult patients with chronic phase and accelerated phase CML with resistance or intolerance to prior therapy including imatinib, and pediatric patients with CML with resistance or intolerance to prior therapy including imatinib.

Nilotinib Accord is a generic of Tasigna, authorized in the European Union since November 2007. Studies have demonstrated the satisfactory quality and bioequivalence of Nilotinib Accord to Tasigna.

Nilotinib Accord will be available as 50-mg, 150-mg, and 200-mg hard capsules. The active substance of Nilotinib Accord is nilotinib, an antineoplastic protein kinase inhibitor that targets BCR-ABL kinase and other oncogenic kinases.

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