New ESMO Guidelines Include FOTIVDA®▼(tivozanib) Recommendation for Patients with Advanced Renal Cell Carcinoma
EUSA Pharma (EUSA) welcomes the news that FOTIVDA®▼ (tivozanib) has been included in the new European Society of Medical Oncology (ESMO) clinical practice guidelines for renal cell carcinoma (RCC), published on 21st February 2019.1
In the new guidelines tivozanib is included as a first-line treatment recommendation for advanced RCC (aRCC) clear cell histology patients. The guidelines have also positioned tivozanib as a treatment standard for good (or favourable) risk patients and a treatment option for intermediate risk patients.1
Dr Bernard Escudier, Medical Oncologist and member of the Genitourinary Tumour Board of Gustave Roussy, France, commented “This is excellent news for patients with metastatic RCC. Outcomes in this disease have greatly improved with the introduction of targeted therapies, meaning that patients are living for longer, although currently available therapies can be associated with burdensome toxicities. We are still in need of effective and well tolerated new treatments in metastatic RCC and thus, tivozanib is a welcomed addition. We also look forward to continuing our investigations of potential combination approaches with other therapeutic agents.”
The inclusion of tivozanib in the new 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 improved progression free survival and lower rates of certain adverse events compared to those receiving another VEGFR-TKI, sorafenib.3
“I am pleased that the important European guidelines have been updated to include tivozanib as a recommendation for first line treatment for aRCC,” commented Lee Morley, Chief Executive Officer, EUSA Pharma. “With kidney cancer expected to be one of the fastest increasing cancers over the next ten years, 4 we remain committed to ensuring the availability of tivozanib across the EU in line with the indication as a monotherapy in the first-line setting treatment of aRCC.”
Kidney cancer is the 12th most commonly occurring cancer5 worldwide – the 9th in men and the 14th in women, with over 400,000 new cases in 2018.6 RCC is the most common form of kidney cancer, accounting for approximately 80% of cases.1
a 1340 microgram capsule
NOTES TO EDITORS
Tivozanib is an oral, once-daily,b 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 aRCC.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.
b 1340 microgram capsule
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 Escudier B, Porta C, Schmidinger M et al. Renal Cell Carcinoma: ESMO Clinical Practice Guidelines For Diagnosis and Treatment Follow Up. Available at: https://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. Last accessed March 2019.
2 European Medicines Agency. Fotivda. Available at: https://www.ema.europa.eu/medicines/human/EPAR/fotivda. Last accessed March 2019.
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 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 March 2019.
5 World Cancer Research Fund, Kidney cancer. Available at: https://www.wcrf.org/dietandcancer/kidney-cancer. Last accessed March 2019.
6 World Cancer Research Fund, Kidney cancer statistics. Available at: https://www.wcrf.org/dietandcancer/cancer-trends/kidney-cancer-statistics. Last accessed March 2019.
Open Health Patient & Brand Communications
Tel +44 (0)207 861 2808
Om 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.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Key UK SEP Patent Win for TQ Delta20.3.2019 19:03:00 CET | Pressemelding
TQ Delta LLC, a technology development and licensing firm, secured a judgment on March 18 by the High Court of Justice of England and Wales immediately enjoining ZyXEL Communications UK Ltd and its Danish parent company, ZyXEL Communications A/S, from further infringement of TQ Delta's European Patent (UK) 1 453 268. TQ Delta's patent relates to Digital Subscriber Line ("DSL") technology. In an earlier judgment, handed down on March 12, the Court found that the patent was valid and essential to the operation of ADSL2 and VDSL2. In that judgment, the Court held that the ZyXEL defendants have infringed and continue to infringe the patent. The Court also found that a second patent would have also been essential and infringed but was invalid. In its judgment earlier this week, the Court also found that the ZyXEL defendants were "holding out" against taking a licence to TQ Delta's portfolio of patents relating to DSL. It granted an immediate injunction and costs against the ZyXEL defendants
Lehman Brothers Treasury Announces the Successful Auction of a Portion of its Intercompany Claim against Lehman Brothers Holdings Inc.20.3.2019 18:15:00 CET | Pressemelding
In connection with its previously announced partial wind-down, Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”), through its U.S. counsel Kramer Levin Naftalis & Frankel LLP, announced that its placement agent, Seaport Loan Products LLC, successfully concluded an auction of a US$10,475,844,413 portion of LBT’s US$34,548,000,000 intercompany claim (the “Intercompany Claim”) against Lehman Brothers Holdings Inc. for a total gross purchase price of US$179,472,166. The sale is expected to close during the first week of April 2019. The net proceeds of the sale (after deducting various sale-related costs and expenses), together with certain available cash, will be used to fund a final distribution to creditors of LBT who do not receive substitute notes as a result of LBT’s prior solicitation process. For more information on the partial wind-down, including information about the Intercompany Claim sale, the final cash distribution, and anticipated timelines, an Information Notice has
Susan Ochs Joins PSB as Global Head, Financial Services20.3.2019 17:34:00 CET | Pressemelding
PSB, a global research-based consultancy, announced today that Susan Ochs has joined the firm as Senior Vice President and Global Head, Financial Services, effective immediately. Ochs is based in New York and is responsible for the global development of the financial services practice and will contribute to other industry practices as well. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190320005671/en/ Susan Ochs, SVP, Global Head, Financial Services, PSB (Photo: Business Wire) “We are proud of the amazing brands we currently partner with across the financial sector,” said Mike Chuter, CEO, PSB, to whom Ochs reports. “With Susan’s combination of private and public finance expertise we’ll be able to deliver even more meaningful insights to our current and future partners. We are delighted to welcome Susan and are excited about the deep experience she brings.” Ochs has more than two decades of experience across the financial
Corsair Infrastructure Partners Announces Long Term Investments by HarbourVest Partners20.3.2019 14:35:00 CET | Pressemelding
Corsair Infrastructure Partners (“CIP”), the global infrastructure investment business of Corsair Capital (“Corsair”), today announced that HarbourVest Partners (“HarbourVest”), a leading institutional investor active across multiple asset classes and geographies, has invested in three new CIP-managed funds established to deploy capital in the aviation, port, and road sectors. Earlier this year, CIP’s new funds closed on the acquisitions of shareholdings in three platform companies – the airport developer Vantage Airport Group, the Australian stevedore DP World Australia, and the Spanish toll-road operator Itínere Infraestructuras – from various selling shareholders including Gateway Infrastructure Investments, a legacy CIP-managed vehicle. The investments from HarbourVest come from a long-term pool of institutional capital dedicated to supporting infrastructure equity sponsors like CIP, and will play an important role in the execution of CIP’s growth strategies for all three platforms
Fishawack continues to build best-in-class service offering with Dudnyk acquisition20.3.2019 13:00:00 CET | Pressemelding
Fishawack, a leading independent healthcare communications specialist, is excited to announce its acquisition of Dudnyk, the Philadelphia-based healthcare communications agency. Dudnyk is an award-winning, full-service agency that specializes in creating insight-driven, authentic brand experiences that unite specialty physicians and their patients. They leverage strategic, scientific, and creative capabilities to serve clients in the biotech, pharmaceutical, and medical device industries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190320005204/en/ Dudnyk leadership team includes Christopher Tobias, PhD, President; Laurie Bartolomeo, EVP, Creative Director; Drew Desjardins, EVP, Chief Strategy Officer; Annemarie Armstrong, EVP, Director of Client Services; John Kemble, EVP, Creative Producer. (Photo: Business Wire) Fishawack’s goal is to increase the range of healthcare communications services that it can offer to commerc
ExaGrid Nominated in Six Categories for the 2019 Network Computing Awards20.3.2019 12:00:00 CET | Pressemelding
ExaGrid ®, a leading provider of intelligent hyperconverged storage for backup, today announced that it has been nominated in six categories for the 2019 Network Computing Awards. ExaGrid has become a finalist for Data Centre Product of the Year, The Return on Investment Award, Hardware Product of the Year, Product of the Year, The Customer Service Award, and Company of the Year. Voting to determine the winner in each category is underway now and closes on April 23. The results will be revealed at an evening award ceremony in London on May 2. ExaGrid’s model EX63000E backup storage appliance with data deduplication is a nominee in four categories. The model provides the largest scale-out system and offers up to a 2PB full backup with an ingest rate of 432TB/hr, which is three times faster than any other backup storage on the market. “We are thrilled to be nominated by IT staff, and recognized by Network Computing, in six prestigious categories this year,” said Bill Andrews, CEO and Pre