Correction: Ipsen announces U.S. FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma
Thursday, June 15, 2023
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The review is based on positive results from the pivotal Phase III NAPOLI 3 trial, in which the Onivyde regimen demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS), compared to nab-paclitaxel plus gemcitabine, with a safety profile consistent with the profiles of the treatment components. These results were presented at the January 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).
“PDAC is a devastating disease in need of additional treatment options. The FDA’s decision to accept the sNDA for this Onivyde-based regimen in treatment-naïve patients with metastatic disease represents an important milestone in the potential treatment of this complex form of cancer,” said Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. “We’re committed to developing therapies which have the potential to make a meaningful difference to the lives of people living with cancer and look forward to working with FDA as they review this application.”
The FDA provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of Ipsen’s application. In 2020, the FDA granted Ipsen Fast Track designation for Onivyde as a first-line combination treatment for mPDAC. The FDA’s Fast Track program facilitates the development and expedites the review of medicines that treat serious conditions and have the potential to address an unmet medical need.
About the NAPOLI 3 trialError! Bookmark not defined.
NAPOLI 3 is a randomized, open-label Phase III trial of an investigational Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for mPDAC. NAPOLI 3 enrolled 770 patients across 205 trial site locations in 18 countries. Patients were randomized to receive Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine (n=387) administered three times a month (days 1, 8, 15 of a 28-day cycle).
About Onivyde
Onivyde is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In Onivyde, irinotecan is enclosed in tiny fat particles called liposomes, which accumulate in the tumor and release slowly over time.
Onivyde is currently approved in most major markets including the U.S., the E.U. and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with mPDAC after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with mPDAC.
Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent pharmaceutical company with an international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.
About PDAC
PDAC is the most common type of cancer that forms in the pancreas with approximately 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally.2,3 Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV).4 Even in later stages, weight loss, abdominal pain and jaundice are the most common symptoms making PDAC difficult to detect.5 Despite significant advances in cancer treatments since the 1970s, no treatment options for PDAC significantly extend life.4 Currently, fewer than 20% of people diagnosed with PDAC survive longer than one year and, overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.2,3
U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA
Fatal neutropenic sepsis occurred in 0.8% of patients receiving Onivyde. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving Onivyde in combination with 5-FU and LV. Withhold Onivyde for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.
Severe diarrhea occurred in 13% of patients receiving Onivyde in combination with 5-FU/LV. Do not administer Onivyde to patients with bowel obstruction. Withhold Onivyde for diarrhea of Grade 2–4 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, if not contraindicated, for early diarrhea of any severity.
CONTRAINDICATION
Onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to Onivyde or irinotecan hydrochloride.
Warnings and precautions
Severe neutropenia: see boxed WARNING. In patients receiving Onivyde/5-FU/LV, the incidence of Grade 3/4 neutropenia was higher among Asian (18/33 [55%]) vs White patients (13/73 [18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of Asian vs 1% of White patients.
Severe diarrhea: see boxed WARNING. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed.
Interstitial lung disease (ILD): Irinotecan HCl can cause severe and fatal ILD. Withhold Onivyde patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue Onivyde in patients with a confirmed diagnosis of ILD.
Severe hypersensitivity reactions: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue Onivyde in patients who experience a severe hypersensitivity reaction.
Embryo-fetal toxicity: Onivyde can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during and for 1 month after Onivyde treatment.
For further information:
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