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Fotivda Shows Better Outcomes Than Combo in Metastatic Kidney Cancer
Patients with metastatic renal cell carcinoma (RCC) — a type of kidney cancer — did not experience benefits after receiving a combination of Opdivo (nivolumab) and Fotivda (tivozanib). Patients previously experienced disease progression (worsening) on or after treatment with a PD-(L)1 inhibitor. Findings were based on the phase 3 TiNivo-2 study and presented at the 2024 ESMO Congress. Study…
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Fotivda (Indications)
In this article, we will discuss Fotivda (Indications). So, let’s get started. Therapeutic IndicationsFotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) 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.
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2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs #fdaapproval #MSL #FSTP #BoardcertifiedMSL #BCMSLcert “Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. With the COVID-19 crisis stretching into its third year, the 2021 batch of new drug approvals clearly demonstrates that the sector has learned how to operate in a pandemic. All told, the industry nabbed 55 FDA approvals in 2021. They include the controversial accelerated approval for Biogen's Alzheimer's drug Aduhelm, Pfizer's record-shattering COVID-19 vaccine, Comirnaty, and many others. Not all 2021 approvals commanded as many headlines as Aduhelm and Comirnaty. Aside from those notable companies, also represented in 2021's crop of new approvals were Amgen, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Regeneron. And among the dozens of new drugs green-lit last year, companies such as BridgeBio, ChemoCentryx and Apellis won their first-ever FDA approvals, setting them up to make their commercial debuts. RELATED: FDA missing more approval target dates as COVID slows inspections Yet, some applications did face pandemic challenges. The FDA struggled to keep up with its inspection duties during the pandemic, leading to regulatory delays for certain drugmakers. In November, the agency reported that 55 new drug applications were facing inspection delays. Avadel Pharmaceuticals and UCB were among those to experience inspection-related delays in 2021. “ 2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs 1. #Verquvo 2. #Cabenuva 3. #Lupkynis 4. #Tepmetko 5. #Ukoniq 6. #Breyanzi 7. #Evkeeza 8. #Cosela 9. Amondys 45 10. #Pepaxto 11. #Nulibry 12. #Azstarys 13. #Fotivda 14. #Ponvory 15.#Zegalogue 16. #Abecma 17. #Qelbree 18. #Nextstellis 19. #Jemperli 20. #Zynlonta 21. #Empaveli 22. #Rybrevant 23. #Lybalvi 24. #Truseltiq 25. #Lumakras … https://lnkd.in/gwV7JXXe https://www.instagram.com/p/CYVaOqVpos3/?utm_medium=tumblr
#fdaapproval#msl#fstp#boardcertifiedmsl#bcmslcert#verquvo#cabenuva#lupkynis#tepmetko#ukoniq#breyanzi#evkeeza#cosela#pepaxto#nulibry#azstarys#fotivda#ponvory#zegalogue#abecma#qelbree#nextstellis#jemperli#zynlonta#empaveli#rybrevant#lybalvi#truseltiq#lumakras
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A Preview of ASCO 2021; a Moble App to help Prove a Traveler Health Status after Receiving the COVID-19 Vaccine; National Cancer Act at 50
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Tivozanib, ティボザニブ塩酸塩水和物
Tivozanib
Molecular FormulaC22H19ClN4O5
Average mass454.863 Da
AV951 AV951 (KRN951, Tivozanib) AV-951; AV951;AV 951 AV-951|KRN-951|VEGFR tyrosine kinase inhibitor IV KRN 951 1-{2-Chloro-4-[(6,7-diméthoxy-4-quinoléinyl)oxy]phényl}-3-(5-méthyl-1,2-oxazol-3-yl)urée 1-{2-Chloro-4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl}-3-(5-methyl-1,2-oxazol-3-yl)urea 475108-18-0 [RN] FREE FORM AV 951 N-(2-chlor…
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Global Liver Cancer Treatment Market Trends | Segmentation, Outlook, Industry Report to 2021-2027
The global liver cancer treatment market is anticipated to grow at a CAGR of 10.2% during the forecast period (2021-2027). The rising change in lifestyle of people such as consumption of alcohol, rising prevalence of liver cancer cases, increasing awareness for the treatment of cancer, and rising FDA approvals, are driving the liver cancer treatment market during the forecast period. For instance, according to the WHO data, globally, in 2020, there were around 905,677 (4.7%) new liver cancer cases and 830,180 (8.3%) deaths due to liver cancer.
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In March 2020, the US Food and Drug Administration (FDA) has approved Bristol Myers Squibb's liver cancer drug combination. Patients with hepatocellular carcinoma (HCC), one of the most aggressive and widespread forms of liver cancer, will receive the Opdivo (nivolumab) plus Yervoy (ipilimumab) drug treatment. Apart from it, in March 2020, Dicerna Pharmaceuticals, Inc., a developer of investigational ribonucleic acid interference (RNAi) therapeutics, has announced that it has received the US FDA approval for orphan drug designation (ODD) to Dicerna's DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency. A1AT deficiency is a hereditary condition that can lead to lung and liver disease. Children with the disease's liver manifestations may experience jaundice (yellowing of the skin and whites of the eyes) and scar tissue formation in the liver (cirrhosis). Adults with liver disease can develop cirrhosis, progress to liver failure, or develop hepatocellular carcinoma, a form of liver cancer.
A Full Report of Global Liver Cancer Treatment Market is Available at: https://www.omrglobal.com/industry-reports/liver-cancer-treatment-market
Furthermore, in December 2018, AVEO Oncology has announced a partnership with AstraZeneca to evaluate the efficacy of the company’s drugs. In a Phase 1/2 trial, AstraZeneca's IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), was used in conjunction with AVEO's FOTIVDA(tivozanib), an oral, and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) in first-line hepatocellular carcinoma (HCC), or liver cancer. However, the demand for the treatment of cancers, new drugs, FDA approvals, and device launches, and the increasing prevalence of cancer patients could impede the global liver cancer diagnosis and treatment market over the coming years.
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Global Liver Cancer Treatment Market Report Segment
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US
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Germany
United Kingdom
France
Spain
Italy
Rest of Europe
Asia-Pacific
China
Japan
India
Rest of Asia-Pacific
Rest of the World
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Could Kyowa Kirin be eyeing oncology use for cancer drug tivozanib?
Kyowa Kirin has bought back rights outside of cancer to tivozanib, amending an agreement dating back to 2006 with AVEO, and opening up the possibility of research in ophthalmology.
Under the terms of the deal Kyowa Kirin will buy back the non-cancer rights of tivozanib in territories included in the deal, which covers the US and EU.
This also excludes rights sublicensed to EUSA Pharma, which markets the drug under the brand name Fotivda in Europe for kidney cancer.
This amends the deal in 2006 which granted AVEO exclusive rights to tivozanib in all indications.
Kyowa Kirin will make an upfront payment of $25 million to AVEO and waive the latter’s obligation to make an $18 million milestone payment upon marketing approval, and up to $391 million in payments upon achievement of certain development and commercial objectives in non-oncology uses.
The Japanese pharma is not saying how it intends to develop tivozanib, but tivozanib is a vascular endothelial growth factor (VEGF) inhibitor, which works by inhibiting the growth of blood vessels that feed tumours.
VEGF inhibitors are also used in ophthalmology – Novartis’ Lucentis (ranibizumab) is an antibody that inhibits VEGF that has already been approved in ophthalmology indications such as wet age-related macular degeneration (AMD).
In this disease, blood vessels proliferate in the back of the eye, scarring it and leading to loss of central vision.
VEGF inhibitors work against these blood vessels, improving the vision of people affected by AMD and similar diseases.
Roche’s Avastin (bevacizumab), another VEGF drug used in cancer, is not approved in ophthalmology but is used off-label in diseases such as wet AMD as it is cheaper to administer than Lucentis.
Kyowa Kirin gave no further details about what the “non-oncology” uses agreement covers but ophthalmology has proven to be a highly lucrative market for Novartis and its rival Bayer, which markets another VEGF drug, Eylea (aflibercept).
Tivozanib has already been studied in mice with choroidal neovascularisation, with results suggesting a possible use in neovascular AMD.
And as the VEGF inhibitors on the market are expensive biologic drugs, repurposing a small molecule drug such as tivozanib could give Kyowa Kirin wiggle-room in terms of pricing should clinical trials go well.
The post Could Kyowa Kirin be eyeing oncology use for cancer drug tivozanib? appeared first on Pharmaphorum.
from Pharmaphorum https://pharmaphorum.com/news/could-kyowa-kirin-be-eyeing-oncology-use-for-cancer-drug-tivozanib/
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Cancer du rein : le tivozanib supérieur au sorafénib en 3e/4e ligne
L'inhibiteur de tyrosine kinase du VEGFR tivozanib (Fotivda*, Aveo/Eusa Pharma en France) s'est montré supérieur au sorafénib (Nexavar*, Bayer) en traitement de 3e ou 4e ligne du carcinome à cellules rénales avancé, dans une étude de phase III publiée par le Lancet Oncology.
Le traitement du cancer du rein s'est enrichi ces dernières années avec plusieurs inhibiteurs de tyrosine kinase du VEGFR autorisés en 1ère et 2e ligne ainsi que plus récemment des immunothérapies par inhibiteurs de checkpoint. Mais on a besoin de traitements pour les patients réfractaires à ces thérapies, rappellent Brian Rini de la Cleveland Clinic et ses collègues.
Le tivozanib a montré une amélioration de la survie sans progression face au sorafénib dans l'étude TIVO-1 en première ligne. Il n'y avait pas de bénéfice en survie globale, en raison d'un taux élevé de cross-over des patients sous sorafénib vers le tivozanib, mais cela a permis de montrer que ce dernier avait une efficacité élevée chez des patients ayant déjà reçu un inhibiteur du VEGFR.
C'est pourquoi il a été évalué dans TIVO-3 chez des patients ayant déjà reçu des inhibiteurs du VEGFR.
Dans l'étude, les 350 patients qui ont été randomisés entre le tivozanib et le sorafénib avaient reçu 2 inhibiteurs du VEGFR dans 45% des cas, une association inhibiteur du VEGFR/immunothérapie dans 25% et d'autres associations incluant un inhibiteur du VEGFR pour les autres.
Le tivozanib a permis d'augmenter le taux de réponse (18% contre 8% de réponses partielles) et d'obtenir une médiane de survie sans progression de 5,6 mois, comparé à 3,9 mois avec le sorafénib.
A un an, le taux de survie sans progression était plus que doublé, à 28% avec le tivozanib contre 11% avec le sorafénib. A 2 ans, les proportions étaient respectivement de 18% et 5%.
Le bénéfice semblait concerner principalement les patients présentant un niveau de risque favorable selon le critère IDMC: la médiane de survie sans progression s'élevait à 11,1 mois contre 6 mois.
Un bénéfice était observé chez les patients ayant déjà eu un traitement par inhibiteur de checkpoint.
Chez les répondeurs, une durée de réponse supérieure à un an était observée chez 71% des patients avec le tivozanib contre 46% avec le sorafénib.
Il n'y avait pas de différence significative de survie globale.
Les auteurs soulignent le fait que le profil de sécurité apparaît meilleur que celui des autres inhibiteurs du VEGFR avec "une faible incidence d'effets indésirables de classe et d'ajustements de dose".
Dans un éditorial, Axel Bex de l'University College à Londres et de l'Institut du cancer des Pays-Bas à Amsterdam souligne le fait que l'algorithme de traitement des carcinomes à cellules rénales est en pleine évolution avec la place croissante prise par les immunothérapies, et qu'il est pour le moment difficile de dire quelle sera la place du tivozanib. Il espère qu'arriveront des biomarqueurs permettant de personnaliser le traitement séquentiel de ce cancer.
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Optimising advanced RCC treatment: the place of Fotivda(tivozanib) in 2019 and beyond
http://dlvr.it/R1w9WY
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New ESMO Guidelines Include FOTIVDA®▼(tivozanib) Recommendation for Patients with Advanced Renal Cell Carcinoma
New ESMO Guidelines Include FOTIVDA®▼(tivozanib) Recommendation for Patients with Advanced Renal Cell Carcinoma
HEMEL HEMPSTEAD, England–(BUSINESS WIRE)–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…
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FOTIVDA expected to be included in new ESMO guidelines for advanced renal cell carcinoma
EUSA Pharma welcomes the news that FOTIVDA (tivozanib) is expected to be included in the upcoming European Society of Medical Oncology clinical practice guidelines for advanced renal cell carcinoma, anticipated to be published at the end of this year. from The Medical News https://ift.tt/2Jb2N5K
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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
-ENDS-
NOTES TO EDITORS
About tivozanib
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.
References
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20181022005345/en/
Contacts
EUSA Pharma Lee Morley, +44 (0) 330 5001140 Chief Executive or Reynolds-MacKenzie Chiara Ennas, +44 (0) 207 861 2558
from Financial Post https://ift.tt/2R79jND via IFTTT Blogger Mortgage Tumblr Mortgage Evernote Mortgage Wordpress Mortgage href="https://www.diigo.com/user/gelsi11">Diigo Mortgage
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Tivozanib, ティボザニブ塩酸塩水和物
Tivozanib Molecular FormulaC22H19ClN4O5 Average mass454.863 Da AV951 AV951 (KRN951, Tivozanib) AV-951; AV951;AV 951 AV-951|KRN-951|VEGFR tyrosine kinase inhibitor IV KRN 951 1-{2-Chloro-4-[(6,7-diméthoxy-4-quinoléinyl)oxy]phényl}-3-(5-méthyl-1,2-oxazol-3-yl)urée 1-{2-Chloro-4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl}-3-(5-methyl-1,2-oxazol-3-yl)urea 475108-18-0 [RN] FREE FORM AV 951…
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Aveo Oncology announces positive NICE recommendation for FOTIVDA
Aveo Oncology announces positive NICE recommendation for FOTIVDA
Aveo Oncology announces positive NICE recommendation for FOTIVDA Aveo Oncology announces positive NICE recommendation
AVEO Oncology (AVEO) announced that the United Kingdom’s National Institute for Health and Care Excellence has published a Final Appraisal Determination recommending FOTIVDA for the first line treatment of adult patients with advanced renal cell carcinoma.
In the European Union,…
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AZ begins liver cancer immunotherapy tie-up with AVEO
AstraZeneca has announced a collaboration with US biotech AVEO oncology to investigate a potential cancer immunotherapy combination in liver cancer.
AZ’s Imfinzi (durvalumab) immunotherapy has suffered a series of setbacks but the Anglo-Swedish pharma is still trying to find ways to enhance the drug’s effects by combining it with other medicines.
In this case AZ is looking to combine Imfinzi, an anti PD-L1 class drug, with AVEO’s Fotivda (tivozanib), in first line hepatocellular carcinoma.
Fotivda is an oral, once-daily, potent and highly selective vascular endothelial growth factor tyrosine kinase inhibitor, and the two drugs will be initially tested in a phase 1/2 study.
AVEO will serve as the study sponsor, with study costs shared equally by both parties and clinical drug supplied by each respective company. The phase 1 portion of the study is expected to begin in 2019.
AVEO is also testing Fotivda in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) PD-1 cancer immunotherapy in renal cell carcinoma.
An oral, once daily, vascular endothelial growth factor tyrosine kinase inhibitor discovered by Kyowa Hakko Kirin, Fotivda inhibits all three VEGF receptors and is designed to minimise off-target toxicities and side effects.
The companies hope that this will have a synergistic effect with Imfinzi, which works by flipping a chemical switch, allowing the body’s own T-cells to recognise cancer cells and attack them.
Michael Bailey, president and CEO of AVEO, said: “We are thrilled to collaborate with AstraZeneca to explore another tivozanib-immunotherapy combination and look forward to understanding the potential of combining tivozanib with durvalumab in liver cancer.
“TKI-immunotherapy combinations have demonstrated important clinical potential across multiple tumour types, though toxicities associated with these combinations have limited their potential use. Our goal is to establish tivozanib as the TKI of choice for use with immunotherapies by demonstrating efficacy with reduced toxicity.”
Fotivda is marketed in Europe and certain other countries by UK-based EUSA Pharma.
Although approved in a niche lung cancer use, and previously treated patients with bladder cancer, Imfinzi has failed in several other trials – most notably the lucrative first-line lung cancer indication where Merck’s Keytruda (pembrolizumab) is dominant.
The post AZ begins liver cancer immunotherapy tie-up with AVEO appeared first on Pharmaphorum.
from Pharmaphorum https://pharmaphorum.com/news/az-begins-liver-cancer-immunotherapy-tie-up-with-aveo/
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BRIEF-Aveo Oncology announces Fotivda approved in the EU for the treatment of advanced renal cell carcinoma
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