On March 24, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that the National Comprehensive Cancer Network (NCCN) has included ONIVYDE (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin in its 2016 Clinical Practice Guidelines in Oncology for pancreatic adenocarcinoma (Press release, Merrimack, MAR 24, 2016, View Source [SID:1234509915]). Schedule your 30 min Free 1stOncology Demo! The new guidelines recognize the ONIVYDE regimen as a category 1 second-line therapy for patients with metastatic adenocarcinoma of the pancreas who have previously been treated with gemcitabine-based therapy. A category 1 classification represents the highest level of evidence and uniform NCCN consensus that the intervention is appropriate. The new guidelines are published on www.nccn.org .
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"The addition of the ONIVYDE regimen to the 2016 NCCN guidelines further validates the importance of this treatment option for patients battling metastatic pancreatic cancer," said Edward J. Stewart, Head of Commercial at Merrimack. "ONIVYDE is the only FDA approved therapy available to patients whose disease has progressed after gemcitabine-based therapy and, more importantly, it addresses a critical unmet need in a patient population with very limited options. We believe these guidelines will further support the adoption of the ONIVYDE regimen as a standard-of-care in metastatic pancreatic cancer."
Pancreatic cancer is a rare and deadly disease. Each year approximately 53,000 patients are diagnosed with pancreatic cancer in the United States with only 7% surviving five years or longer1. The NCCN’s recommendation was based on a review by a multidisciplinary panel of experts from NCCN member institutions and supported by data from the NAPOLI-1 study, published in The Lancet in 2015, and the U.S. Food and Drug Administration (FDA) approval of the ONIVYDE regimen. NAPOLI-1 was a randomized, open label Phase 3 study in patients with metastatic adenocarcinoma of the pancreas who received prior gemcitabine-based therapy, and was the largest Phase 3 study in this setting to date. Patients were enrolled at 76 sites in North America, South America, Europe, Asia and Oceania.
NCCN is an alliance of 26 world-class cancer centers dedicated to the development of treatment guidelines for most cancers and to research that will ultimately improve the quality of patient care and outcomes. The NCCN guidelines are widely recognized as the standard of clinical practice in oncology and provide evidence-based treatment recommendations to assist key stakeholders, including physicians, patients and payers, in directing cancer patient care.
About ONIVYDE [pronounced \ ‘on – īh – vide \]
ONIVYDE (irinotecan liposome injection), also known as MM-398 or "nal-IRI," is a novel encapsulation of irinotecan in a liposomal formulation. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death. ONIVYDE was recently approved by the U.S. Food and Drug Administration in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. For full prescribing information, including Boxed WARNING, please visit www.ONIVYDE.com.