At its meeting on June 27, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorizations to four anti-cancer therapies.
Balversa
The CHMP has approved the authorization of Balversa (erdafitinib, Janssen-Cilag International NV) 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 with sensitive genetic alterations of FGFR3. These patients must have already received at least one line of treatment containing a PD-1 inhibitor (Programmed Death receptor 1) or PD-L1 inhibitor (Programmed Death-Ligand 1PD-L1) in the treatment of unresectable or metastatic disease.
Urothelial carcinoma is the most common form of bladder cancer, 9th most commonly diagnosed cancer worldwide. In 2022, approximately 614,000 new cases of bladder cancer and 220,000 deaths were reported worldwide.
The highest incidence rates in both men and women are observed in Southern Europe. Greece recorded 5,800 new cases and 1,537 deaths in 2018. Spain has the highest incidence rate in men worldwide. Since the 1990s, bladder cancer incidence trends have diverged by sex, with rates decreasing or stabilizing in men but increasing in women in some European countries.
The CHMP recommendation is based on data from cohort 1 of theTHOR test phase III study, which compared erdafitinib to standard chemotherapy (docetaxel or vinflunine, investigator’s choice). Cohort 1 included 266 adults with advanced urothelial cancer with selected alterations in FGFR3.
All patients had disease progression following one or two prior therapies, at least one of which included a PD-1 or PD-L1 inhibitor. The primary efficacy endpoints were overall survival, progression-free survival, and objective response rate (ORR).
The treatment with erdafitinib reduced the risk of death by 36% compared with chemotherapy (hazard ratio [HR] : 0,64 ; p = 0.005). Median overall survival was 12.1 months in the erdafitinib arm, versus 7.8 months in the chemotherapy arm. Median progression-free survival was 5.6 months in the erdafitinib arm, versus 2.7 months in the chemotherapy arm (HR: 0.58; p = 0.0002). The ORR was 35.3% with erdafitinib, versus 8.5% with chemotherapy.
Balversa will be available as 3, 4 and 5 mg film-coated tablets. Erdafitinib, the active substance in Balversa, is an antineoplastic protein kinase inhibitor that suppresses fibroblast growth factor receptor tyrosine kinases (Fibroblast Growth Factor ReceptorFGFR). Deregulation of FGFR3 signaling is involved in the pathogenesis of urothelial cancer and inhibition of FGFR has demonstrated antitumor activity in FGFR-expressing cells.
Ordspono
The Committee adopted a positive opinion for Ordspono (odronextamab, Regeneron Ireland Designated Activity Company), indicated as monotherapy for the treatment of adult patients with:
- relapsed or refractory follicular lymphoma (RRFL) following at least two lines of systemic therapy;
- relapsed or refractory diffuse large B-cell lymphoma (rDLBCL) following at least two lines of systemic therapy.
The recommendation for authorization is based on phase II trials (NCT02290951, NCT03888105), which demonstrated elevated ORs in patients with rrLF and rrDLBCL.
In the LDGCB cohort, a TRO of 49% was achieved in previously treated patients who had not received chimeric antigen receptor T-cell therapy. Overall, 31% of patients achieved a complete response.
The LF cohort obtained a response rate of 82% in patients with grades I–IIIA disease, while 75% of the overall population achieved a complete response.
Ordspono will be available as a 2 mg, 80 mg and 320 mg concentrate for solution for infusion. The active substance in Ordspono is odronextamab, a bispecific antibody that targets CD20-expressing B cells and CD3-expressing T cells. By binding to both cell types, it induces T cell activation and generates a polyclonal cytotoxic T cell response, leading to lysis of malignant B cells.
Generics
Positive reviews were also issued for two generic cancer drugs.
Enzalutamide Viatris (enzalutamide) is indicated for the treatment of adult men with prostate cancer in several scenarios:
- as monotherapy or in combination with androgen deprivation therapy for non-metastatic hormone-sensitive prostate cancer at high risk of recurrence in men who are unable to receive salvage radiotherapy;
- in combination with androgen deprivation therapy for hormone-sensitive metastatic prostate cancer;
- for high-risk non-metastatic castration-resistant prostate cancer (CRPC);
- for metastatic CRPC in asymptomatic or mildly symptomatic men following failure of androgen deprivation therapy, when chemotherapy is not yet indicated;
- for metastatic CRPC in men whose disease has progressed on or following treatment with docetaxel.
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 compared to Xtandi.
Enzalutamide Viatris will be available as 40 mg and 80 mg film-coated tablets. The active substance in Enzalutamide Viatris is enzalutamide, a hormone antagonist that blocks multiple steps in the androgen receptor signalling pathway.
Nilotinib Accord (nilotinib) is indicated for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML).
It is used in adult and pediatric patients with newly diagnosed CML in chronic phase, in adult patients with CML in chronic phase and accelerated phase who are resistant or intolerant to prior therapy including imatinib, and in pediatric patients with CML who are resistant or intolerant 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 compared to Tasigna.
Nilotinib Accord will be available as 50 mg, 150 mg and 200 mg hard capsules. The active substance in Nilotinib Accord is nilotinib, an antineoplastic protein kinase inhibitor that targets BCR-ABL kinase and other oncogenic kinases.
This article was translated from Medscape.com using multiple editorial tools, including AI, in the process. The content was reviewed by the editorial staff before publication.
EMA Approves Four New Anti-Cancer Therapies
Balversa for Urothelial Carcinoma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorizations for Balversa (erdafitinib, Janssen-Cilag International NV) for the treatment of urothelial carcinoma. This type of cancer affects the bladder and urinary system.
Balversa is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with sensitive genetic alterations of FGFR3. These patients must have already received at least one line of treatment containing a PD-1 inhibitor (Programmed Death receptor 1) or PD-L1 inhibitor (Programmed Death-Ligand 1 PD-L1) in the treatment of unresectable or metastatic disease.
Urothelial carcinoma is the most common form of bladder cancer, the 9th most commonly diagnosed cancer worldwide. In 2022, approximately 614,000 new cases of bladder cancer and 220,000 deaths were reported globally. The highest incidence rates in both men and women are observed in Southern Europe. Greece recorded 5,800 new cases and 1,537 deaths in 2018. Spain has the highest incidence rate in men worldwide. Since the 1990s, bladder cancer incidence trends have diverged by sex, with rates decreasing or stabilizing in men but increasing in women in some European countries.
The CHMP recommendation is based on data from cohort 1 of the THOR test phase III study, which compared erdafitinib to standard chemotherapy (docetaxel or vinflunine, investigator’s choice). Cohort 1 included 266 adults with advanced urothelial cancer with selected alterations in FGFR3.
All patients had disease progression following one or two prior therapies, at least one of which included a PD-1 or PD-L1 inhibitor. The primary efficacy endpoints were overall survival, progression-free survival, and objective response rate (ORR).
Treatment with erdafitinib reduced the risk of death by 36% compared to chemotherapy (hazard ratio [HR]: 0,64; p = 0.005). Median overall survival was 12.1 months in the erdafitinib arm, versus 7.8 months in the chemotherapy arm. Median progression-free survival was 5.6 months in the erdafitinib arm, versus 2.7 months in the chemotherapy arm (HR: 0.58; p = 0.0002). The ORR was 35.3% with erdafitinib, versus 8.5% with chemotherapy.
Balversa will be available as 3, 4 and 5 mg film-coated tablets. Erdafitinib, the active substance in Balversa, is an antineoplastic protein kinase inhibitor that suppresses fibroblast growth factor receptor tyrosine kinases (Fibroblast Growth Factor Receptor FGFR). Deregulation of FGFR3 signaling is involved in the pathogenesis of urothelial cancer, and inhibition of FGFR has demonstrated antitumor activity in FGFR-expressing cells.
Ordspono for Follicular Lymphoma and Diffuse Large B-cell Lymphoma
The Committee adopted a positive opinion for Ordspono (odronextamab, Regeneron Ireland Designated Activity Company), indicated as monotherapy for the treatment of adult patients with:
- Relapsed or refractory follicular lymphoma (RRFL) following at least two lines of systemic therapy.
- Relapsed or refractory diffuse large B-cell lymphoma (rDLBCL) following at least two lines of systemic therapy.
The recommendation for authorization is based on phase II trials (NCT02290951, NCT03888105), which demonstrated elevated ORs in patients with rrLF and rrDLBCL.
In the LDGCB cohort, a TRO of 49% was achieved in previously treated patients who had not received chimeric antigen receptor T-cell therapy. Overall, 31% of patients achieved a complete response.
The LF cohort obtained a response rate of 82% in patients with grades I–IIIA disease, while 75% of the overall population achieved a complete response.
Ordspono will be available as a 2 mg, 80 mg and 320 mg concentrate for solution for infusion. The active substance in Ordspono is odronextamab, a bispecific antibody that targets CD20-expressing B cells and CD3-expressing T cells. By binding to both cell types, it induces T cell activation and generates a polyclonal cytotoxic T cell response, leading to lysis of malignant B cells.
Generic Cancer Drugs
Positive reviews were also issued for two generic cancer drugs.
Enzalutamide Viatris
Enzalutamide Viatris (enzalutamide) is indicated for the treatment of adult men with prostate cancer in several scenarios:
- As monotherapy or in combination with androgen deprivation therapy for non-metastatic hormone-sensitive prostate cancer at high risk of recurrence in men who are unable to receive salvage radiotherapy.
- In combination with androgen deprivation therapy for hormone-sensitive metastatic prostate cancer.
- For high-risk non-metastatic castration-resistant prostate cancer (CRPC).
- For metastatic CRPC in asymptomatic or mildly symptomatic men following failure of androgen deprivation therapy when chemotherapy is not yet indicated.
- For metastatic CRPC in men whose disease has progressed on or following treatment with docetaxel.
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 compared to Xtandi.
Enzalutamide Viatris will be available as 40 mg and 80 mg film-coated tablets. The active substance in Enzalutamide Viatris is enzalutamide, a hormone antagonist that blocks multiple steps in the androgen receptor signaling pathway.
Nilotinib Accord
Nilotinib Accord (nilotinib) is indicated for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML).
It is used in adult and pediatric patients with newly diagnosed CML in chronic phase, in adult patients with CML in chronic phase and accelerated phase who are resistant or intolerant to prior therapy including imatinib, and in pediatric patients with CML who are resistant or intolerant 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 compared to Tasigna.
Nilotinib Accord will be available as 50 mg, 150 mg and 200 mg hard capsules. The active substance in Nilotinib Accord is nilotinib, an antineoplastic protein kinase inhibitor that targets BCR-ABL kinase and other oncogenic kinases.
This article was translated from Medscape.com using multiple editorial tools, including AI, in the process. The content was reviewed by the editorial staff before publication.
