Generics
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 (CRPC).
- 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.
A version of this article appeared on Medscape.com.