INNOVAXA®
(innovacitabine 150mg tablets)
A breakthrough treatment for advanced oncology patients, demonstrating superior efficacy in clinical trials.
Proven Efficacy
67% overall response rate in Phase III clinical trials with 2,847 patients.
Fast Acting
Median time to response: 4.2 weeks, with durable responses lasting 18+ months.
Manageable Profile
Well-tolerated with predictable and manageable side effects in most patients.
Clinical Evidence
INNOVAXA has demonstrated significant improvement in progression-free survival compared to standard of care in multiple randomized controlled trials.
AURORA Study Results
Study Design
- • Randomized, double-blind, placebo-controlled
- • 2,847 patients with advanced solid tumors
- • 24-month follow-up period
- • Primary endpoint: progression-free survival
- • Secondary endpoints: overall survival, safety
Clinical Evidence
INNOVAXA has demonstrated significant improvement in progression-free survival compared to standard of care in multiple randomized controlled trials.
AURORA Study Results
Study Design
- • Randomized, double-blind, placebo-controlled
- • 2,847 patients with advanced solid tumors
- • 24-month follow-up period
- • Primary endpoint: progression-free survival
- • Secondary endpoints: overall survival, safety
Indication & Usage
INNOVAXA is indicated for the treatment of adult patients with locally advanced or metastatic solid tumors who have received at least one prior systemic therapy and whose tumors have specific biomarker expressions as detected by an FDA-approved test.
Dosage and Administration
The recommended dose is 150 mg taken orally twice daily, approximately 12 hours apart, with or without food. Continue treatment until disease progression or unacceptable toxicity.
Patient Selection
Select patients for treatment based on the presence of specific tumor biomarkers. Information on FDA-approved tests is available at www.fda.gov/CompanionDiagnostics.
Important Safety Information
INNOVAXA may cause severe side effects including hepatotoxicity. Monitor liver function tests before and during treatment.
Most common adverse reactions (≥20%) were fatigue (67%), nausea (45%), diarrhea (38%), and decreased appetite (32%).
Serious adverse reactions occurred in 28% of patients. The most common serious adverse reactions were pneumonia (3.2%) and febrile neutropenia (2.8%).
INNOVAXA can cause embryo-fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
Monitor complete blood count weekly for the first month, then monthly. Dose reductions may be required for hematologic toxicities.
Report any unusual bleeding, bruising, persistent fever, or signs of infection to your healthcare provider immediately.
Contraindications & Warnings
INNOVAXA is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).
Not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).
QT prolongation may occur. Monitor ECG in patients with heart disease or those taking QT-prolonging medications.
Drug interactions with strong CYP3A4 inhibitors may increase INNOVAXA exposure. Avoid concomitant use or reduce dose.
This is a brief summary. Please see full Prescribing Information for complete safety details and dosing recommendations.