Irinotecan liposome is approved by the USFDA for first-line treatment of metastatic pancreatic adenocarcinoma

Irinotecan liposome is approved by the USFDA for first-line treatment of metastatic pancreatic adenocarcinoma

Share This Post

The Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin on February 13, 2024, for treating metastatic pancreatic adenocarcinoma as the initial therapy.

NAPOLI 3 (NCT04083235) was a randomized, multicenter, open-label, active-controlled trial with 770 people who had pancreatic adenocarcinoma that had spread to other parts of the body and had never been through chemotherapy in this stage before. It looked at how well the treatment worked. Randomization was categorized based on area, liver metastases, and ECOG performance status. Patients were randomly assigned, in a 1:1 ratio to receive one of the specified therapies.

NALIRIFOX regimen consists of irinotecan liposome at a dosage of 50 mg/m2 administered intravenously over 90 minutes, followed by oxaliplatin at a dosage of 60 mg/m2 administered intravenously over 120 minutes, followed by leucovorin at a dosage of 400 mg/m2 administered intravenously over 30 minutes, followed by fluorouracil at a dosage of 2400 mg/m2 administered intravenously over 46 hours, with this cycle repeated every 2 weeks.
Administer Nab-paclitaxel at a dose of 125 mg/m2 intravenously over 35 minutes, followed by gemcitabine at a dose of 1000 mg/m2 intravenously over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
The primary efficacy measure was overall survival (OS). Other effectiveness criteria were investigator-assessed progression-free survival (PFS) and objective response rate (ORR). NAPOLI 3 showed a substantial increase in overall survival (OS) and progression-free survival (PFS) for the NALIRIFOX group compared to the Gem+NabP group. The median overall survival was 11.1 months (95% CI: 10.0, 12.1) in the NALIRIFOX group and 9.2 months (95% CI: 8.3, 10.6) in the Gem+NabP group. The Hazard Ratio (HR) was 0.84 (95% CI: 0.71, 0.99) with a p-value of 0.0403. The median progression-free survival was 7.4 months (95% CI: 6.0, 7.7) in the NALIRIFOX group and 5.6 months (95% CI: 5.3, 5.8) in the Gem+NabP group (HR 0.70 [95% CI: 0.59, 0.85]; p-value 0.0001). The objective response rate (ORR) was 41.8% (95% CI: 36.8, 46.9) in the NALIRIFOX group and 36.2% (95% CI: 31.4, 41.2) in the Gem+NabP group.

The primary side effects of NALIRIFOX, with a notable difference compared to Gem+NabP, were diarrhea, exhaustion, nausea, vomiting, decreased appetite, gastrointestinal pain, mucosal inflammation, constipation, and decreased weight. The prevalent laboratory abnormalities (≥10% Grade 3 or 4) included reduced neutrophils, potassium, lymphocyte, and hemoglobin levels.

The suggested dosage of irinotecan liposome is 50 mg/m2 given through intravenous infusion lasting 90 minutes every 2 weeks. Administer irinotecan liposome prior to oxaliplatin, fluorouracil, and leucovorin. No specific dosage of irinotecan liposome is advised for patients with blood bilirubin levels beyond the upper limit of normal.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Adagrasib with cetuximab has received accelerated approval by FDA for KRAS G12C-mutated colorectal cancer
Colon cancer

Adagrasib with cetuximab has received accelerated approval by FDA for KRAS G12C-mutated colorectal cancer

The FDA has granted accelerated approval to Adagrasib combined with Cetuximab for treating KRAS G12C-mutated colorectal cancer. This approval is based on promising clinical trial results showing enhanced efficacy of the drug duo. Adagrasib, a KRAS inhibitor, and Cetuximab, an EGFR inhibitor, together target the cancer more effectively, offering new hope for patients with this specific genetic mutation, aiming to improve survival rates and treatment outcomes.

Pembrolizumab with chemotherapy is approved by the USFDA for primary advanced or recurrent endometrial carcinoma
Endometrial cancer

Pembrolizumab with chemotherapy is approved by the USFDA for primary advanced or recurrent endometrial carcinoma

The USFDA has approved Pembrolizumab combined with chemotherapy for treating primary advanced or recurrent endometrial carcinoma. This approval is based on clinical trial data showing significant improvements in patient outcomes. Pembrolizumab, an immune checkpoint inhibitor, works by enhancing the body’s immune response against cancer cells. This combination therapy offers a new and promising treatment option for patients facing this challenging and often aggressive cancer.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy