On July 8, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial and clinical development stage biopharmaceutical company, reported that it will host a key opinion leader (KOL) webinar focusing on FOTIVDA (tivozanib), AVEO’s oral, once-daily, differentiated vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies, on Friday, July 16, 2021 at 12:00 p.m. Eastern Time (Press release, AVEO, JUL 8, 2021, View Source [SID1234584726]).
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The webinar will feature presentations by KOLs Thomas Hutson, D.O., Pharm.D. (Baylor University Medical Center) and Brian Rini, M.D. (Vanderbilt-Ingram Cancer Center) who will discuss the evolving RCC treatment landscape as well as the results of the Phase 3 TIVO-3 study of FOTIVDA and its potential role in the treatment of RCC patients who have received two or more prior systemic therapies. This presentation will be followed by a discussion with Laurence Albigès, M.D., Ph.D. (Gustave Roussy Institute) who will review the TiNivo study results and the planned Phase 3 TiNivo-2 study design. Drs. Hutson, Rini and Albigès will be available to answer questions following the formal presentations.
AVEO’s management team will provide a brief company overview and discuss the market opportunity and launch strategy for FOTIVDA. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA in March 2021 for the treatment of adult patients with relapsed or refractory RCC following two or more prior systemic therapies. FOTIVDA recently surpassed 300 total commercial prescriptions since its March 22, 2021 launch.
A live webcast of the webinar can be accessed by the public by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be available for a limited time.
TIVO-3 is a Phase 3 study that enrolled patients with metastatic RCC whose disease progressed on two or more prior systemic regimens.
The randomized, open-label, controlled TiNivo-2 Phase 3 trial of FOTIVDA in combination with OPDIVO (nivolumab) is expected to enroll approximately 326 patients with advanced RCC who have progressed following prior immunotherapy treatment.
About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.
INDICATIONS
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.
Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.
Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.
Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.
Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.
Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.
Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.
Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.
ADVERSE REACTIONS
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.
DRUG INTERACTIONS
Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.