Ipsen has achieved a significant milestone with the FDA’s approval of Onivyde for first-line treatment in pancreatic cancer patients. This approval marks a potential paradigm shift in managing metastatic pancreatic adenocarcinoma (mPDAC), offering a promising addition to the treatment arsenal for this challenging disease.
Onivyde, also known as pegylated liposomal irinotecan, is now endorsed by the FDA for use in conjunction with the NALIRIFOX regimen, which includes oxaliplatin, 5-fluorouracil (5-FU), and leucovorin. This approval signals a breakthrough as the first new treatment option for previously untreated mPDAC patients in over a decade.
The pivotal phase 3 NAPOLI-3 study provided compelling evidence of Onivyde’s efficacy compared to the standard first-line treatment regimen, featuring Bristol-Myers Squibb’s Abraxane (nab-paclitaxel) plus gemcitabine. Notably, patients receiving the Onivyde regimen experienced improvements in both overall survival (OS) and progression-free survival (PFS) metrics.
The study revealed a statistically significant extension in OS to 11.1 months compared to 9.2 months observed in the control group, with a corresponding increase in PFS to 7.4 months from 5.6 months with Abraxane/gemcitabine.
Onivyde’s Approval Marks a Leap in Pancreatic Cancer Treatment
Previously, Onivyde secured FDA approval as a second-line treatment in combination with 5-FU and leucovorin for mPDAC patients following disease progression post-gemcitabine-based therapy. The NAPOLI-3 trial results mark a notable milestone as the first regimen to demonstrate superiority over Abraxane plus gemcitabine in this patient cohort.
Pancreatic ductal adenocarcinoma (PDAC) remains the most prevalent form of pancreatic cancer, contributing to significant morbidity and mortality worldwide. Its insidious nature often leads to late-stage diagnosis due to varied symptoms and diagnostic challenges. Patients with mPDAC face a bleak prognosis, with fewer than one in five surviving beyond one year following diagnosis.
Julie Fleshman, President, and Chief Executive of the Pancreatic Cancer Action Network (PanCAN), emphasizes the profound impact of each approved treatment in offering hope to future patients and extending quality time for those currently battling pancreatic cancer.
Transforming Pancreatic Cancer Treatment and Expanding Patient Reach
For Ipsen, the expansion of Onivyde into the first-line treatment landscape represents a pivotal opportunity to reach a broader patient population. Onivyde stands as one of Ipsen’s premier cancer drugs, with robust sales reaching €164 million ($176 million) last year. While Servier oversees sales of Onivyde outside the US, precise figures remain undisclosed due to Servier’s status as a privately held entity.
In its fourth-quarter results statement, Ipsen noted sustained growth of Onivyde in the US market, albeit offset by reduced sales to Servier resulting from revised manufacturing agreements.
The FDA’s approval of Onivyde as a first-line therapy not only underscores Ipsen’s commitment to advancing cancer care but also signifies a significant advancement in managing mPDAC. With its potential to redefine the treatment landscape, Onivyde heralds a new era of hope and possibility for patients confronting this formidable disease.
Resource: Pharmaphorum, February 14, 2024
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