Outline of New ESMO Guidelines Indicates Inclusion of FOTIVDA®▼ (Tivozanib) for Patients with Advanced Renal Cell Carcinoma
EUSA Pharma (EUSA) welcomes the news that FOTIVDA®▼ (tivozanib) is expected to be included in the upcoming European Society of Medical Oncology (ESMO) clinical practice guidelines for advanced renal cell carcinoma (aRCC), anticipated to be published at the end of this year.1
The outline of the new proposed guidelines was presented on 19th October at the annual ESMO 2018 Congress in Munich, Germany, and indicated that tivozanib will be included as a first-line treatment recommendation for aRCC clear cell histology patients. The update will position tivozanib as a treatment standard for good (or favourable) risk patients with a Class IIa recommendation, and a treatment option for intermediate risk patients with a Class IIb recommendation.1
The indication of inclusion of tivozanib in the ESMO guidelines follows the grant of a European Commission (EC) licence in August 2017 for this oral, once-daily,a potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI) as first-line treatment of adult patients with aRCC.2
The authorisation within the European Union (EU) was based on evidence from the global, open-label, randomised, multi-centre Phase III trial TiVO-1,3 which showed that aRCC patients receiving tivozanib experienced superior progression free survival and an improved side effect profile compared to those receiving another VEGFR-TKI, sorafenib.3
“EUSA Pharma are pleased to receive this indication of the inclusion of tivozanib in such important European guidelines reflecting both its EU authorisation and the potential patient benefits as a result of its efficacy and tolerability profile,” said Lee Morley, Chief Executive, EUSA Pharma. “We continue to progress the launch of FOTIVDA across the EU in line with the indication as a monotherapy in the first-line setting treatment of advanced renal cell carcinoma.”
Kidney cancer is the seventh most common cancer in Europe4 and the 14th worldwide,5 with over 400,000 new cases in 2018.5 RCC is the most common form of kidney cancer, accounting for 80% of cases6 and there are an estimated 49,000 deaths from kidney cancer each year in Europe, 143,000 globally. 7 Kidney cancer is expected to be one of the fastest increasing cancers over the next ten years as a result of Europe’s ageing population, with smoking and a rise in obesity also playing a part.8
NOTES TO EDITORS
Tivozanib is an oral, once-daily,a potent selective vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKI). It is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.2
An over-expression of VEGF protein, and a resulting increase in tumour blood supply (angiogenesis), is a common feature of RCC.3 VEGFR-TKIs reduce the supply of blood to the tumour and are the recommended first-line treatment for advanced RCC in Europe, however, patients often experience significant side effects including fatigue, diarrhoea, and hand-foot syndrome.
In the global Phase III trial (TiVO-1)3 of over 500 patients with advanced RCC, tivozanib demonstrated a significant progression free survival (PFS) benefit versus sorafenib (11.9 vs. 9.1 months in the overall patient population [HR, 0.797; 95% CI, 0.639 to 0.993; P =.042], and 12.7 vs. 9.1 months in treatment-naïve patients [HR, 0.756; 95% CI, 0.580 to 0.985; P =.037]).3 There was also an improved side-effect profile versus sorafenib, with significantly fewer patients on tivozanib (14% versus 43%) requiring a dose reduction due to AEs; and less than 5% of patients experiencing severe side effects (grade 3&4, such as diarrhoea, asthenia (physical weakness) and hand-foot syndrome. Hypertension (44%) and dysphonia (21%) were the most commonly reported AEs on tivozanib.3
Under EUSA Pharma’s license agreement with AVEO PHARMACEUTICALS, INC, announced in December 2015, the company holds exclusive commercialisation rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialisation of the product in its territories, assuming licensing. AVEO PHARMACEUTICALS, INC retains the rights to commercialise the product in North America. Tivozanib was discovered by Kyowa Hakko Kirin.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has commercial operations in the United States and Europe, and a wider distribution network in approximately 40 countries around the world. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information, please visit www.eusapharma.com.
1 Systemic first-line treatment of ccRCC, as part of the “State of the art for systemic treatments in kidney and bladder cancers” presented at ESMO 2018 congress, Munich, 19th October 2018.
2 European Medicines Agency. Fotivda. Available at: https://www.ema.europa.eu/medicines/human/EPAR/fotivda. Last accessed October 2018.
3 Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial. Journal of Clinical Oncology. Volume 31. 2013: 30:3791
4 Cancer Research UK, Kidney Cancer Incidence. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/incidence#heading-Ten. Last accessed October 2018.
5 World Cancer research Fund, Kidney cancer statistics. Available at: https://www.wcrf.org/dietandcancer/cancer-trends/kidney-cancer-statistics. Last accessed October 2018.
6 Escudier B; Porta C et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 27 (Supplement 5). 2016: v58–v68. Available at: http://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. Last accessed October 2018.
7 Cancer Research UK. Kidney Cancer Statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer#heading-One. Last accessed October 2018.
8 Cancer Research UK. Kidney cancer rates are increasing, so what’s fuelling the surge? Available at: http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/. Last accessed October 2018.
a 1340 microgram capsule
Lee Morley, +44 (0) 330 5001140
Chiara Ennas, +44 (0) 207 861 2558
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
The “Centre Hospitalier de la Côte Basque” in France Has Started the Evaluation of the Biolog-id’s C-LOG® Solution20.6.2019 18:35:00 EEST | Tiedote
The Centre Hospitalier de la Côte Basque (CHCB) in Bayonne has been using Biolog-id's C-LOG® solution since early April 2019. This solution secures and optimizes the circuit of chemotherapy and immunotherapy, from their preparation all the way to the administration to the patient. The C-LOG® solution has been used at the CHCB. "During the last HAS audit, a lack of traceability was revealed in the chemotherapy circuit. In order to close this gap, we decided to install the C-LOG® solution which, in addition to securing the administration to the patient's bed, makes it possible to trace the preparation circuit from the pharmacy to the reception in the nurses station," says Dr. Burtin, Pharmacist at CHCB. The solution will be tested for evaluation for 3 months before final adoption. "The RFID (Radio Frequency Identification) technology is the foundation of our solution. The tag affixed on each preparation contains the product and patient data. This information is updated in real-time and c
CSC Announces Cyber Security Findings for the Media Industry20.6.2019 18:00:00 EEST | Tiedote
Securing a company’s digital infrastructure has become a major concern to corporations worldwide. With leading security companies and other organizations alerting corporations and the public to recent widespread, state-sponsored domain name system (DNS) hijacking, more and more brands are starting to take action. CSC has been issuing Cyber Security Reports since 2017, culling the most important information about security risks, and in particular, risks to brands that are not mitigated by a traditional firewall. The recent research conducted by CSC focuses on the media industry, revealing that 78% of global media brands use a corporate domain registrar, yet only 37% of those have a registrar lock to protect their DNS from hijacking. Recent domain hijacking, unauthorized changes, and deletion of vital domains have shown that effectively managing domain names and DNS must become a critical component for enhancing the security posture of any company with an online presence. More worrisome
Arch Capital Group Names Seamus Fearon EVP, Credit Risk Transfer and Services, Global Mortgage Group20.6.2019 16:00:00 EEST | Tiedote
Arch Capital Group Ltd. (Arch) today announced that Seamus Fearon has been promoted to Executive Vice President, Credit Risk Transfer and Services, Global Mortgage Group. In this role, Fearon will have responsibility for managing Arch’s credit risk transfer (CRT) business and growing its credit risk services offerings. He most recently was Chief Actuary of Arch’s Global Mortgage Group, where he oversaw its capital management framework and the development of its analytics and modeling capabilities. This newly created role highlights Arch’s focus on participating in credit risk transfer programs and supporting customers who would like to enter that growing market. “As the mortgage insurance market in the U.S. becomes even more competitive, it’s important for Arch to diversify its mortgage business to ensure we remain at the forefront of the industry,” said David Gansberg, CEO of Arch’s Global Mortgage Group. “Seamus brings both an analytical perspective and business acumen to these units
Hot Wheels Teams Up With Nintendo to Bring the World of Mario Kart to Fans With New Die-cast Toy Line20.6.2019 16:00:00 EEST | Tiedote
Today Hot Wheels and Nintendo announce the global release of Hot Wheels Mario Kart die-cast vehicles and track sets. With its introduction, the beloved Nintendo characters and iconic karts from the hugely popular Mario Kart franchise have been transformed into authentic, high-performance die-cast toy vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190620005167/en/ Three Hot Wheels Mario Kart game-inspired track sets will be available this summer. (Photo: Business Wire) The Hot Wheels replica line features 1:64th scale die-cast Mario Kart vehicles that can race, stunt and crash on a variety of Hot Wheels Mario Kart track sets that bring the gameplay to life. The die-cast karts are also compatible with existing Hot Wheels sets. At launch the Hot Wheels Mario Kart Replica Die-cast assortment will include Mario, Yoshi, Luigi and Bowser with many additional characters coming soon such as Princess Peach, Koopa Troopa and
Lumileds Highlights Environmental, Health and Safety Milestones in First Sustainability Report20.6.2019 16:00:00 EEST | Tiedote
Lumileds, a global leader in innovative lighting solutions, today released its 2018 Sustainability Report, which details the company’s progress in supporting the transition to a worldwide low-carbon economy. In the report, Lumileds highlights how its lighting solutions are contributing to positive changes in energy usage, safety, and health and wellness, supporting the company’s commitment to making the world safer, better and more beautiful with light. Lumileds follows a formalized sustainability agenda that identifies specific priorities and tracks progress. For example, in its global LED and automotive lighting operations, the company recently surpassed its 2020 operational goals relative to 2015 including: 41% reduction in emissions (20% goal) 25% reduction in energy consumption (20% goal) 25% reduction in water usage (20% goal) The sustainability objectives are based on creating value for customers through sustainable innovations, reducing the environmental footprint of the compan
Cargo Screening Technology by Smiths Detection at the Mega Tema Port Expansion in Ghana20.6.2019 14:22:00 EEST | Tiedote
Smiths Detection has won a contract with Meridian Port Services Limited (MPS) to provide cargo inspection technology for the major Tema Port Expansion project in Ghana - designed to accommodate the world’s largest container ships, improve cargo handling productivity and increase trade to both Ghana and the rest of Africa. Four Smiths Detection HCVPZ60 scanning portals were selected to deliver the Ghanaian authorities more efficient border security, while safeguarding state revenue derived from duties and taxes on containerised goods. With trade anticipated to grow in Ghana in the coming years, these portals have been selected in part because of their ability to facilitate fast and effective security processing of a high volume of container traffic. The HCVPZ60 can penetrate 9-11.8 inches of steel whilst maintaining a throughput of up to 100 trucks per hour. Smiths Detection’s advanced screening technology, iCMORE will also be deployed, to expose containers falsely declared as empty. Th
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme