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
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Servier announce updated overall survival results of exploratory TASCO1 phase II study of LONSURF® + bevacizumab in a first-line setting for patients with unresectable mCRC non-eligible for intensive therapy17.1.2021 00:15:00 EET | Press release
Servier announced today updated results from the exploratory phase II TASCO1 study evaluating LONSURF® (trifluridine/tipiracil) + bevacizumab and capecitabine + bevacizumab (C-B) in a first-line setting for patients with unresectable metastatic colorectal cancer (mCRC) who are non-eligible for intensive therapy.1 The data were announced today during an oral presentation at the 2021 ASCO Gastrointestinal Cancers Symposium (ASCO-GI). Patients with mCRC who are not eligible for chemotherapy face a large unmet need, with fewer treatment options available to them and lower survival rates. Colorectal cancer (CRC) makes up 9.7% of total global cancer cases, with almost 1.4 million new cases of CRC each year.2 In Europe, CRC is the second most common cause of death due to cancer, and those with a metastatic disease have a 5-year survival rate of just 11%.3 “For patients with metastatic colorectal cancer, those non-eligible for standard combination therapy have few options left and we are conti
H.I.G. Realty Invests in Production Studios & Content Hub in Madrid15.1.2021 11:00:00 EET | Press release
H.I.G. Capital, LLC ("H.I.G."), a leading global alternative investment firm with $43 billion of equity capital under management, announced today that one of its affiliates has invested in Madrid Content City, an approximately 140,000 square meter hub with state of the art audio-visual facilities, including production studios, production & post-production technical facilities, and a university focused on media studies. H.I.G. continues to add to its sizeable portfolio of real estate assets across Europe, consisting of both equity as well as debt investments, with a particular focus on its target market of value-added small and midcap opportunities. Riccardo Dallolio, Managing Director and Head of H.I.G. Europe Realty Partners, commented: “Madrid Content City will benefit from strong secular tailwinds underpinned by the boom in content production. The state-of-the-art studios and related facilities, the exceptional multinational tenant line-up with long term leases, and its critical mas
Eurofins, the global leader in analytical testing, expands worldwide face mask testing & certification capabilities15.1.2021 09:30:00 EET | Press release
Since the start of the pandemic Eurofins (Paris:ERF) has tested thousands of models of surgical and hygienic masks and provided best-in-class speed and certification for PPEs globally, enabling these critical products to get market as fast as possible. Eurofins has developed global leading testing capabilities and certification services in the North America, Europe and Asia ensuring that PPE manufacturers are able to provide the indispensable support needed in the fight against the coronavirus. As of today, Eurofins is one of the few GLP certified and ISO/IEC 17025 accredited laboratory networks to fully cover all testing requirements for surgical/medical and hygienic masks by the FDA, EU regulations and many international and country-specific directives and guidelines such as CEN, CE Marking, ISO, ASTM or OECD. Our robust portfolio for masks includes globally accepted, safety and performance testing, virucidal, bacterial filtration, particle filtration, differential pressure, biocompa
TOXINS 2021: New analyses of pivotal Phase III trial data highlight long duration of response for Dysport® (abobotulinumtoxinA) in five therapeutic indications15.1.2021 09:00:00 EET | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) announced results from new analyses of pivotal Phase III clinical trial data to assess treatment intervals over repeat cycles of Dysport® (abobotulinumtoxinA [aboBoNT-A]) in five patient populations. AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations is being shared during the TOXINS 2021 conference, which is taking place virtually between 16-17 January 2020 and is organized by the International Neurotoxin Association.1-28 Ipsen is sharing 26 abstracts during the congress, with data including updates from the recently published surveys into the experience of patients and caregivers, data from the Phase IV ULIS-III trial, and ten abstracts focused on basic science research into neurotoxins.1-27 Spasticity is one of the most common and disabling conditions associated with many neurological conditions in adults and is characterized by velocity-dependent muscle hypertonia. Spasticity can lead to disabilit
Velodyne Lidar Commends NHTSA Plan to Update NCAP14.1.2021 23:58:00 EET | Press release
Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today commended the U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) plan to update to its New Car Assessment Program (NCAP). The NHTSA proposal would add four advanced driver assistance system (ADAS) capabilities to the NCAP, keeping pace with evolving safety technologies and providing much-needed information to consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210114005992/en/ Images show vehicle with lidar-based PAEB stopping before adult target @ 50% overlap (above) and vehicle with camera and radar-based PAEB crashing into adult target (below). (Photo: Velodyne Lidar, Inc.) NCAP is the U.S. Government’s premier consumer information program for evaluating vehicle safety performance. The NHTSA proposal to add ADAS technologies to the NCAP includes pedestrian automatic emergency braking, lane keeping support, blind spot warning and
Veristat Supported Marketing Applications for 10% of All FDA Novel Drug Approvals in 202014.1.2021 21:15:00 EET | Press release
Veristat, a scientific-minded global clinical research organization (CRO), announced today that they supported the marketing applications for 10% of the 2020 US Food and Drug Administration (FDA) novel drug approvals. The FDA approved 53 novel drugs, defined by the FDA as New Molecular Entities (NMEs)i, and Veristat regulatory, statistical, and medical writing experts were integral in preparing five of these NME New Drug Applications. Veristat also prepared NDA/BLAs for three non-NME FDA approvals and one Marketing Authorization Application (MAA) that received approval in Europe. "Despite the global challenges in 2020, Veristat continued to advance its mission of helping clients achieve regulatory approval of novel medical therapies," stated Patrick Flanagan, Chief Executive Officer at Veristat. "Now, more than ever, Veristat is focused on providing expert guidance to facilitate the rapid approval for therapies that improve the lives of patients and their families around the world." Ve
Tigo Energy Raises $20 Million in Funding14.1.2021 19:33:00 EET | Press release
Tigo Energy, Inc., the worldwide leader in Flex-MLPE (Module Level Power Electronics) today announced a $20 million round of investment, led by Energy Growth Momentum. “2020 has been a breakout year for Tigo and 2021 has the potential for even greater success,” stated Zvi Alon, Chairman and CEO of Tigo. “We are excited to have the EG Momentum team’s support and their working capital will enable us to better serve our current customer base and invest in the future expansion with new customers, new partners and new projects.” The investment will be used to improve upon existing products and develop next generation solutions that maximize returns for PV customers. A portion of the new funds will be used to efficiently and effectively scale. Tigo’s growth has accelerated significantly recently as the company’s products have reached more customer segments and countries throughout the world. With over 40,000 installations in over 100 countries on all 7 continents, Tigo systems generate more
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom