Lonsurf(trifluridine and tipiracil)

Oncology· 625 cited findings· 4 source documents

What the regulatory reviews say

Lonsurf (trifluridine and tipiracil) is a drug reviewed for its efficacy and safety. In one study, it demonstrated a median Overall Survival (OS) of 7.1 months, with a hazard ratio of 0.68 and a p-value of <0.001. Progression-Free Survival (PFS) events were 472. Another study reported a median OS of 10.8 months, a hazard ratio of 0.61, and a p-value of <0.001, with 206 Progression-free survival events and a median PFS of 5.6 months.

Safety findings include a Grade 3-4 neutropenia rate of 38% and 52%, a Grade 3-4 anemia rate of 17%, and a Grade 3-4 thrombocytopenia rate of 4%. Aspartate aminotransferase increased (All Grades) was observed in 34% of patients. Deaths due to neutropenic infection/sepsis were 3, and deaths due to septic shock were 4. Pulmonary emboli incidence was 2%. The drug received Marketing Authorisation approval on 22 September 2015.

Key figures — cited to the source page

Median OS	7.1	TAIHO ONCOLOGY — Lonsurf FDA Review, p.28
Hazard ratio (OS)	0.68	TAIHO ONCOLOGY — Lonsurf FDA Review, p.28
Median OS	10.8	TAIHO ONCOLOGY — Lonsurf FDA Review, p.30
Hazard ratio (OS)	0.61	TAIHO ONCOLOGY — Lonsurf FDA Review, p.30
Grade 3-4 neutropenia rate	38	TAIHO ONCOLOGY — Lonsurf FDA Review, p.15
Grade 3-4 anemia rate	17	TAIHO ONCOLOGY — Lonsurf FDA Review, p.15
Pulmonary emboli incidence	2	TAIHO ONCOLOGY — Lonsurf FDA Review, p.18
Marketing Authorisation approval date	22 September 2015	Servier — Lonsurf EMA EPAR public assessment report, p.8

Source documents

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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.