First-Line Liposomal Irinotecan Approved
In February, the US Food and Drug Administration (FDA) approved nal-IRI (Onivyde) as part of a new first-line regimen for first-line metastatic PDAC. In the new regimen (NALIRIFOX), nal-IRI is substituted for the conventional IRI found in FOLFIRINOX, boosting the cost more than 15-fold from around $500-$7800 per cycle.
The FDA approval was based on the results of the NAPOLI-3 study, which did not compare outcomes of NALIRIFOX with FOLFIRINOX, but rather, compared first-line nal-IRI with the combination of nab‐paclitaxel and gemcitabine. The study showed longer OS (HR, 0.83; 95% CI, 0.70-0.99; P = .04) and PFS (HR, 0.69; 95% CI, 0.58-0.83; P < .001), with first-line nal-IRI.
The absence of a head-to-head comparison has some oncologists debating whether the new regimen is a potential new standard first-line treatment or whether the cost outweighs the potential benefits.
One study author reported grants/contracts from AbbVie, Bristol Myers Squibb, Curegenix, Medivir, Merck, and Nouscom; personal/consulting fees from Bayer, Catenion, G1 Therapeutics, Janssen Pharmaceuticals, Merck, Merus, Nouscom, Regeneron, Sirtex Medical Inc., Tango Therapeutics, and Tavotek Biotherapeutics; and support for other professional activities from Bristol Myers Squibb and Merck outside the submitted work. Another study author reported personal/consulting fees from Astellas Pharma, AstraZeneca, IDEAYA Biosciences, Merck, Merus, Moderna, RenovoRx, Seattle Genetics, and TriSalus Life Sciences outside the submitted work. The remaining authors and Picozzi disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.