Fotivda(tivozanib hydrochloride)

Oncology· 324 cited findings· 1 source document

Company: Recordati B V

What the regulatory reviews say

Fotivda (tivozanib hydrochloride) is a new active substance with a recommended dose of 1340 microgram. It received orphan medicinal product designation on 9 June 2010, which was withdrawn on 24 April 2017. The marketing authorization application was submitted on 29 February 2016, and a positive opinion from the CHMP was issued on 22 June 2017.

In a study involving 517 patients (median age 59 years), the primary endpoint was Progression-Free Survival (PFS) by independent radiological review (IRR). The median PFS for tivozanib was 11.9 months (95% CI), compared to 9.1 months (95% CI) for sorafenib, with a PFS HR (95% CI) of 0.797 and a p-value of 0.042. The objective response rate (ORR) by IRR was 33% for tivozanib, with a median duration of response of 15.0 months, compared to 12.9 months for sorafenib.

Safety data from 835 patients who received tivozanib monotherapy showed that 92% experienced any adverse event (Grade 1-4), and 64% experienced any adverse event (Grade 3-4). Hypertension (Grade 1-4) occurred in 45% of patients, with Grade 3-4 hypertension in 26%. In comparison, the sorafenib arm reported 97% for any adverse event (Grade 1-4) and 70% for any adverse event (Grade 3-4).

Key figures — cited to the source page

Median PFS (95% CI) for tivozanib	11.9	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.91
Median PFS (95% CI) for sorafenib	9.1	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.91
PFS HR (95% CI)	0.797	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.91
PFS p-value	0.042	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.92
Any adverse event (Grade 1-4) in tivozanib arm	92	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.95
Any adverse event (Grade 3-4) in tivozanib arm	64	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.95
Hypertension (Grade 1-4) in tivozanib arm	45	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.95
CHMP positive opinion date	22 June 2017	Recordati B V — Fotivda EMA EPAR public assessment report (E, p.9

Source documents

Recordati B V — Fotivda EMA EPAR public assessment report (EMEA/H/C/004131, 2017) (2017)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.