Onkológia 1/2021

Nanoliposomal irinotecan – drug profile

Nanoliposomal irinotecan, (nal-iri, also known as pegylated liposomal irinotecan) was developed with the aim to maximize tissue penetration while minimizing toxicity. NAPOLI-1 was a phase III study testing nal-iri in combination with 5-fluorouracil and leucovorin (5-FU/LV) versus 5-FU/LV monotherapy in patients with metastatic pancreatic cancer after failing previous gemcitabine-based therapy. This registration study demonstrated statistically significant 2 months benefit without negatively impairing quality of life. Thus, nal-iri, in combination with 5-FU/ LV, had become standard treatment for second- or subsequent-line therapy after gemcitabine failure. FDA approved nal-iri in 2015 a EMA in 2016. Recently, in July 2020, FDA has granted fast track designation for the investigational use of liposomal irinotecan in combination with 5-FU/LV and oxaliplatin (NALIRIFOX) based on encouraging results of first-line study (median overall survival 12.6 months).

Keywords: nanoliposomal irinotecan, nal-iri, pancreatic cancer, NAPOLI-1