Approval allows Onivyde (plus oxaliplatin, fluorouracil, and leucovorin) as first-line therapy
By Lori Solomon HealthDay Reporter
THURSDAY, Feb. 15, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Onivyde (irinotecan liposome injection) plus oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a first-line treatment for adults living with metastatic pancreatic adenocarcinoma (mPDAC).
The FDA previously approved an Onivyde regimen (Onivyde plus fluorouracil and leucovorin) for mPDAC following disease progression with gemcitabine-based therapy.
The approval was based on efficacy and safety data from NAPOLI 3, a randomized, open-label, phase III pivotal trial that enrolled 770 adults with mPDAC and without prior treatment from 187 trial site locations in 18 countries. The trial revealed that NALIRIFOX provided a statistically significant improvement in median overall survival of 11.1 months versus 9.2 months in nab-paclitaxel and gemcitabine-treated patients (hazard ratio, 0.84). NALIRIFOX was also associated with a statistically significant improvement in median progression-free survival (7.4 months versus 5.6 months for nab-paclitaxel- and gemcitabine-treated patients; hazard ratio, 0.70).
“With each new approved treatment, there is more hope for those who will be diagnosed in the future and people currently living with pancreatic cancer may have more time with their loved ones,” said Julie Fleshman, president and CEO of Pancreatic Cancer Action Network, in a statement.
Approval of Onivyde was granted to Ipsen.
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