Javlor

Javlor is approved as a monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. The recommended starting dose for Javlor is 320 mg/m², with a reduced starting dose of 280 mg/m² for patients with WHO/ECOG PS 1 or 0 with prior pelvic irradiation.

In efficacy studies, the median overall survival (OS) for the vinflunine + BSC arm was 4.6 months, with a 12% risk of death reduction compared to the BSC arm (Hazard Ratio (OS) 0.88, P-value (OS) 0.0403). In another study, the median OS for the VFL+CAPE arm was 13.9 months, compared to 11.7 months for the CAPE arm, representing an OS difference of 2.2 months. The OS Hazard Ratio was 0.98 (p-value 0.7657), with an updated analysis showing an OS Hazard Ratio of 0.97 (p-value 0.6976). The PFS p-value (investigator assessment) was 0.0007.

Safety findings indicate that blood and lymphatic system disorders occurred in 22.2% of patients in the VFL+CAPE arm versus 12.0% in the CAPE arm. Gastrointestinal events were observed in 62.7% of the VFL+CAPE arm compared to 46.5% in the CAPE arm. General disorders and administration site conditions were reported in 47.5% of the VFL+CAPE arm versus 22.7% in the CAPE arm. Musculoskeletal and connective tissue disorders were seen in 19.6% of the VFL+CAPE arm compared to 3.9% in the CAPE arm. The first Marketing Authorization for Javlor in the European Union was granted on 21st September 2009.