Ipsen Receives FDA Fast Track Designation for Investigational Irinotecan Liposome Injection (ONIVYDE ® ) as a Second-Line Monotherapy Treatment for Small Cell Lung Cancer (SCLC)
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®) in study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, reflecting the unmet medical need.
ONIVYDE® 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® is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
An ongoing Phase III randomized study (RESILIENT; NCT03088813) trial is being conducted to assess the efficacy and safety of investigational irinotecan liposome injection (ONIVYDE®) as a monotherapy for SCLC study patients who have progressed on or after a first-line platinum-based regimen.
“The Fast Track designation of ONIVYDE® as a potential treatment for people living with small cell lung cancer is an extension of Ipsen’s focus and contribution to the treatment landscape in oncology,” said Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen. “With 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.”
Lung 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
ONIVYDE® also received Fast Track designation in June 2020 for first-line irinotecan liposome injection (ONIVYDE®) 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.
Programs 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.
ABOUT ONIVYDE® (irinotecan liposome injection)
Ipsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE® 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® 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® in Taiwan.
INDICATION - UNITED STATES
ONIVYDE® 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® is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
IMPORTANT SAFETY INFORMATION - UNITED STATES
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.
ONIVYDE®is contraindicated in patients who have experienced a severe hypersensitivity reaction to ONIVYDE® or irinotecan HCl
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® I 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
- The most common adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased appetite (44%), stomatitis (32%), and pyrexia (23%)
- The most common Grade 3/4 adverse reactions (≥10%) were diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
- Adverse reactions led to permanent discontinuation of ONIVYDE® in 11% of patients receiving ONIVYDE®/5- FU/LV; The most frequent adverse reactions resulting in discontinuation of ONIVYDE® were diarrhea, vomiting, and sepsis
- Dose reductions of ONIVYDE® for adversereactions occurred in 33% of patients receivingONIVYDE®/5 FU/LV; the most frequent adverse reactions requiring dose reductions were neutropenia, diarrhea, nausea, and anemia
- ONIVYDE® was withheld or delayed for adverse reactions in 62% of patients receiving ONIVYDE®/5- FU/LV; the most frequent adverse reactions requiring interruption or delays were neutropenia, diarrhea, fatigue, vomiting, and thrombocytopenia
- The most common laboratory abnormalities (≥20%) were anemia (97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%), hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia (35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia (29%), and hyponatremia (27%)
- Avoid the use of strong CYP3A4 inducers, if possible, and substitute non-enzyme inducing therapies ≥2 weeks prior to initiation of ONIVYDE®
- Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to starting therapy
- Pregnancy and Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise males with female partners of reproductive potential to use condoms during and for 4 months after ONIVYDE® treatment
- Lactation: Advise nursing women not to breastfeed during and for 1 month after ONIVYDE® treatment
Please see full U.S. Prescribing Information including Boxed WARNING for ONIVYDE®.
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neuroscience, and Rare Diseases. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.5 billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,700 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com
Ipsen’s Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes", "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations, and the outcome of this study or other studies. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of 6 pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2019 Universal Registration Document available on its website (www.ipsen.com).
ONIVYDE® is a registered trademark of Ipsen Biopharm Limited. All other trademarks are the property of their respective owners. © 2020 Ipsen Biopharmaceuticals, Inc. All Rights Reserved. November 2020, ONV-US- 002857
- Key Statistics for Lung Cancer. American Cancer Society. https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Published January 8, 2020. Accessed November 20, 2020.
- What is Lung Cancer. American Cancer Society. https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Published October 1, 2019. Accessed November 25, 2020.
Global Corporate Communications
+44 (0) 7557 267634
Vice President, Investor Relations
+44 (0) 1753 627721
North America Product Communications
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
GPD Companies, Inc. to Acquire Distrupol22.1.2021 14:33:00 CET | Press release
GPD Companies, Inc., an affiliate of One Rock Capital Partners, LLC (“One Rock”), today announced that it has entered into a definitive agreement to acquire Distrupol, a subsidiary of Univar Solutions Inc. (NYSE: UNVR) and a leading European distributor of thermoplastics to the polymer processing industry. Terms of the transaction, which is expected to close in the first half of 2021, were not disclosed. Headquartered in Surrey, England, with broad geographic reach across Europe, Distrupol has provided value-added sales and application development of thermoplastic resins for over 50 years. Through its decades-long relationships with world class supply partners, the company offers a robust array of superior performance products and solutions that meet the needs of diverse end users from leading and emerging industries, such as the consumer, medical, automotive, and electrical sectors, among others. Distrupol caters to over 1,300 customers across 13 countries with a portfolio of over 4,0
Schlumberger Announces Fourth-Quarter and Full-Year 2020 Results22.1.2021 12:50:00 CET | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2020. Fourth-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeDec. 31, 2020Sept. 30, 2020Dec. 31, 2019SequentialYear-on-yearRevenue $5,532 $5,258 $8,228 5% -33%Income (loss) before taxes - GAAP basis $471 $(54) $452 n/m 4%Net income (loss) - GAAP basis $374 $(82) $333 n/m 12%Diluted EPS (loss per share) - GAAP basis $0.27 $(0.06) $0.24 n/m 12% Adjusted EBITDA* $1,112 $1,018 $1,648 9% -33%Adjusted EBITDA margin* 20.1% 19.4% 20.0% 73 bps 6 bpsPretax segment operating income* $654 $575 $1,006 14% -35%Pretax segment operating margin* 11.8% 10.9% 12.2% 90 bps -40 bpsNet income, excluding charges & credits* $309 $228 $545 35% -43%Diluted EPS, excluding charges & credits* $0.22 $0.16 $0.39 37% -44% Revenue by Geography International $4,343 $4,210 $5,834 3% -26%North America 1,167 1,034 2,339 13% -50%Other 22 14 55 n/m n/m $5,532 $5,258 $8,228 5% -33% *These are non-
JEOL: Release of a New Cold Field Emission Cryo-Electron Microscope CRYO ARM™ 300 II (JEM-3300)22.1.2021 07:00:00 CET | Press release
JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new cold field emission cryo-electron microscope (cryo-EM), the CRYO ARM™ 300 II (JEM-3300), to be released in January 2021. This new cryo-EM has been developed based on the concept of "Quick and easy to operate and get high-contrast and high-resolution images". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005316/en/ Cold Field Emission Cryo-Electron Microscope CRYO ARM(TM) 300 II (JEM-3300) (Photo: Business Wire) Development Background Recent dramatic improvement of resolution in single particle analysis (SPA) using cryo-EM has led to SPA as an essential method for structural analysis of proteins. To address this market, JEOL released the CRYO ARM™ 300 in 2017. Equipped with a cold field emission gun (Cold FEG) for enhanced resolution and a cryo-stage for loading multiple samples, the CRYO ARM™ 300 has continued to achieve best-in-class res
ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment21.1.2021 23:12:00 CET | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine— dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.1 Lynn Baxter, Head of North America, ViiV He
Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)21.1.2021 22:30:00 CET | Press release
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by inde
Wistron and Kalray Announce FURIO1200™ Storage Appliance21.1.2021 17:45:00 CET | Press release
Wistron, a leader in ICT (Information and communications technology) products, and Kalray (Paris:ALKAL) (Euronext Growth Paris: ALKAL), a leading provider in new generation of processors specialized in Intelligent Data Processing from Cloud to Edge, announce the availability of FURIO1200™, a 24-Flash-Drive NVMe-oF based storage node appliance, integrating Kalray’s NVMe-oF K200™ smart storage adapter, powered by its MPPA® Coolidge™ intelligent processor, and Wistron LYMMA chassis. FURIO1200™ is a new type of hyper-fast disaggregated storage solution delivering ultra-high throughput and reliability. It is the ideal solution for Cloud Service Providers and Enterprises running applications with intensive AI and Data Analytics workloads as well as to optimize their next generation storage. Data Centers are undergoing a very important revolution due to the explosion of usages, the surge of data to be processed and the exponential growth of the number of machines to be managed to support this
NumAlim Selects Dawex and Orange Business Services for its Data and Services Exchange Platform21.1.2021 17:40:00 CET | Press release
NumAlim announced an agreement with Dawex, the leader in Data Exchange technology, and Orange Business Services, a network-native digital services company, to deploy its agri-food digital exchange platform. By relying on these two leading players, NumAlim chose secure technological solutions guaranteeing the sovereignty of French food data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005722/en/ (Photo: Dawex) As early as Q1 2021, the NumAlim data and services exchange "Hub" will offer 18,000 companies in the food industry the opportunity to valorize, acquire and enrich all types of data: production, consumption, traceability, consumer opinions and research, as well as a wide range of services based on data (trend analysis, reformulation, regulatory watch…). "NumAlim is the answer to the needs for transparency, value creation and trust expressed by the food industry, consumers, and public authorities.” says Jérôme Fr