{"id":36960,"date":"2020-11-30T09:00:00","date_gmt":"2020-11-30T07:00:00","guid":{"rendered":"https:\/\/www.ipsen.com\/?post_type=press_release&p=36960"},"modified":"2023-09-06T18:31:09","modified_gmt":"2023-09-06T16:31:09","slug":"ipsen-receives-fda-fast-track-designation-for-investigational-irinotecan-liposome-injection-onivyde-as-a-second-line-monotherapy-treatment-for-small-cell-lung-cancer-sclc","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/press-releases\/ipsen-receives-fda-fast-track-designation-for-investigational-irinotecan-liposome-injection-onivyde-as-a-second-line-monotherapy-treatment-for-small-cell-lung-cancer-sclc\/","title":{"rendered":"Ipsen receives FDA Fast Track designation for investigational irinotecan liposome injection (ONIVYDE\u00ae) as a second-line monotherapy treatment for small cell lung cancer (SCLC)"},"content":{"rendered":"

PARIS, France,<\/b> 30 November 2020 \u2014<\/b> Ipsen (Euronext: IPN; ADR: IPSEY) today announced the United States Food and Drug Administration (FDA) has granted the company Fast Track designation for irinotecan liposome injection (ONIVYDE\u00ae) in study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, reflecting the unmet medical need.
\nONIVYDE\u00ae is currently approved in the United States and in Europe in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE\u00ae is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
\nAn ongoing Phase III randomized study (RESILIENT; NCT03088813) trial is being conducted to assess the efficacy and safety of investigational irinotecan liposome injection (ONIVYDE\u00ae) as a monotherapy for SCLC study patients who have progressed on or after a first-line platinum-based regimen.
\n\u201cThe Fast Track designation of ONIVYDE\u00ae as a potential treatment for people living with small cell lung cancer is an extension of Ipsen\u2019s focus and contribution to the treatment landscape in oncology,\u201d said Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen. \u201cWith this aggressive and often late-stage diagnosed form of lung cancer, we are proud to be one step closer to making another treatment option available to patients.\u201d
\nLung cancer is the second most common cancer in the United States. In 2020, the American Cancer Society estimates there to be about 228,280 new cases of lung cancer in the US (116,300 in men and 112,520 in women).1 SCLC comprises 10% to 15% of all lung cancers and is a very aggressive form of cancer with about 70% of people having metastatic disease when they are diagnosed.2
\nONIVYDE\u00ae also received Fast Track designation in June 2020 for first-line irinotecan liposome injection (ONIVYDE\u00ae) in combination with 5- fluorouracil\/leucovorin (5-FU\/LV) and oxaliplatin (OX) together, known as NALIRIFOX for study patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC). An ongoing Phase 3 randomized study (NAPOLI-3; NCT04083235) is being conducted to assess the efficacy and safety of NALIRIFOX in study patients who are not previously treated for metastatic pancreatic cancer.
\nPrograms with Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development. In addition, the Fast Track designation program allows for the eligibility for accelerated approval and priority review if relevant study criteria are met and enables a company to submit individual sections of a New Drug Application (NDA) for review on a rolling-submission basis.<\/p>\n

ABOUT ONIVYDE<\/b>\u00ae<\/b> (irinotecan liposome injection)<\/b>
\nIpsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE\u00ae in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 150 countries, is responsible for the commercialization of ONIVYDE\u00ae outside of the United States and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of ONIVYDE\u00ae in Taiwan.<\/p>\n

INDICATION \u2013 UNITED STATES<\/b>
\nONIVYDE\u00ae is approved by the U.S. FDA in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Limitation of Use: ONIVYDE\u00ae is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.<\/p>\n

IMPORTANT SAFETY INFORMATION \u2013 UNITED STATES<\/b><\/p>\n\n\n
BOXED WARNINGS: SEVERE NEUTROPENIA and SEVERE DIARRHEA<\/b>
\nFatal neutropenic sepsis occurred in 0.8% of patients receiving ONIVYDE<\/b>\u00ae. Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving ONIVYDE<\/b>\u00ae in combination with 5-FU and LV.<\/b>
\nWithhold ONIVYDE<\/b>\u00ae for absolute neutrophil count below 1500\/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment.<\/b>
\nSevere diarrhea occurred in 13% of patients receiving ONIVYDE<\/b>\u00ae in combination with 5-FU\/LV. Do <\/b>not administer ONIVYDE<\/b>\u00ae to patients with bowel obstruction. Withhold ONIVYDE<\/b>\u00ae for diarrhea of <\/b>Grade 2\u20134 severity. Administer loperamide for late diarrhea of any severity. Administer atropine, <\/b>if not contraindicated, for early diarrhea of any severity.<\/b><\/td>\n<\/tr>\n<\/table>\n

CONTRAINDICATION<\/b>
\nONIVYDE\u00ae<\/b> is contraindicated in patients who have experienced a severe hypersensitivity reaction to ONIVYDE\u00ae<\/b> or irinotecan HCl<\/p>\n

Warnings and Precautions<\/b>
\nSevere Neutropenia<\/b>: See Boxed WARNING<\/b>. In patients receiving ONIVYDE\u00ae\/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
\nSevere Diarrhea<\/b>: See Boxed WARNING<\/b>. Severe and life-threatening late-onset (onset >24 hours after chemotherapy [9%]) and early-onset diarrhea (onset \u226424 hours after chemotherapy [3%], sometimes with other symptoms of cholinergic reaction) were observed
\nInterstitial Lung Disease (ILD)<\/b>: Irinotecan HCl can cause severe and fatal ILD. Withhold ONIVYDE\u00ae I patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation. Discontinue ONIVYDE\u00ae in patients with a confirmed diagnosis of ILD
\nSevere Hypersensitivity Reactions<\/b>: Irinotecan HCl can cause severe hypersensitivity reactions, including anaphylactic reactions. Permanently discontinue ONIVYDE\u00ae in patients who experience a severe hypersensitivity reaction
\nEmbryo-Fetal Toxicity<\/b>: ONIVYDE\u00ae 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\u00ae treatment<\/p>\n

Adverse Reactions<\/b><\/p>\n