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  5. Drug Trials Snapshot: FOTIVDA
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Drug Trials Snapshot: FOTIVDA

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the FOTIVDA Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

FOTIVDA (tivozanib)
(foh-tiv-dah)
Aveo Pharmaceuticals, Inc.
Approval date: March 10, 2021


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

FOTIVDA is a prescription medicine used to treat adult patients with advance kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and has come back or did not respond to treatment.

How is this drug used?

Take FOTIVDA 1 time each day for 21 days on treatment, followed by 7 days off treatment. This is 1 cycle of treatment (28 days). You will repeat this cycle for as long as your healthcare provider tells you to.

Who participated in the clinical trials?

The FDA approved FOTIVDA based on evidence from one clinical trial of 350 adult patients with advanced kidney cancer (renal cell carcinoma or RCC). The trials was conducted at 120 of sites in 12 of countries in North America and Europe. The number of patients representing efficacy findings may differ from the number of patients representing safety findings due to different pools of study participants analyzed for efficacy and safety.

What are the benefits of this drug?

Patients who received FOTIVDA lived longer without cancer progression in comparison to patients who received sorafenib.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: FOTIVDA worked similarly in males and females
  • Race: The number of patients of races other than White was small. Therefore, differences among races in how well the FOTIVDA worked could not be determined.
  • Age: FOTIVDA worked similarly in patients below and above 65 years of age.

What are the possible side effects?

The most common side effects are fatigue, high blood pressure, diarrhea, decreased appetite, nausea, changes in voice, low thyroid hormone, cough, and pain in the mouth. Serious side effects that may occur with FOTIVDA treatment include high blood pressure, heart problems, blood clots, and bleeding. Other possible serious side effects that may occur with FOTIVDA treatment include protein in the urine and thyroid abnormalities.

Were there any differences in side effects of the clinical trials among sex, race, and age?

  • Sex: Males had slightly fewer side effects on FOTIVDA than sorafenib. Women had slightly more side effects on FOTIVDA than sorafenib.
  • Race: The occurrence of side effects in African American patients could not be determined due to the small number of African American patients. The occurrence of side effects was similar in White and Asian patients; however, Asian patients experienced skin reactions two to three times more frequently than White patients. (See Tables 5 and 6)
  • Age: Patients below 65 years of age had fewer side effects than patients 65 years of age or older among all FOTIVDA trials where patients with RCC participated.

 

DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes how many men and women were enrolled in the clinical trial used to evaluate the efficacy of FOTIVDA.

Figure 1: Baseline Demographics by Sex (Efficacy Population)

Pie chart summarizing how many male and female patients were enrolled in the clinical trial. In total, 254 (73%) male and 96 (27%) female patients participated in efficacy population of the clinical trial.

Source: FDA Review

Figure 2 summarizes the percentage of patients by race enrolled in the clinical trial used to evaluate the efficacy of FOTIVDA.

Figure 2: Baseline Demographics by Race (Efficacy Population)

Pie chart summarizing how many White, Black or African American, Asian, d other patients were in efficacy population of the clinical trial. In total, 332 (95%) White patients, 2 (1%) Black or African American patients, 4 (1%) Asian patients, , and 12 (3%) Other patients participated in the efficacy population of the clinical trial.

Source: FDA Review
*includes Decline to state, Unknown, and Other

Figure 3 summarizes the percentage of patients by age group enrolled in the clinical trial used to evaluate the efficacy of FOTIVDA.

Figure 3: Baseline Demographics by Age (Efficacy Population)

Pie chart summarizing how many patients by age were in the clinical trial. In total, 193 (55%) patients below the age of 65 years of age and 157(45%) patients above the age of 65 years of age participated in efficacy population of the clinical trial.

Source: FDA Review

Figure 4 summarizes how many patients by race were in the combined trials used to evaluate the side effects of FOTIVDA.

Figure 4: Baseline Demographics by Race (Safety Population)

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in safety population of the clinical trial. In total, 951 White patients, 7  Black or African American patients, 39 Asian patients, and 11Other patients participated in the safety population of the clinical trial.

Source: FDA Review

How were the trials designed?

FOTIVDA was evaluated in one clinical trial of 350 adult patients with advanced kidney cancer (renal cell carcinoma or RCC) that had been treated with 2 or more prior medicines and has come back or did not respond to treatment.

The trial compared patients who were randomly assigned to receive either FOTIVDA or sorafenib. Both the patients and the health care providers knew which treatment was being given. The treatment continued until the disease progression or the side effects became too toxic.

The trial compared the length of time patients were alive without progression between the two groups.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo that is compared to the actual drug being tested.
CT: Computed tomography.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
HAND-FOOT SKIN REACTION: A common reaction that patients have when taking certain type of medication for RCC. The symptoms usually begin a few weeks after beginning therapy, and may include dry, thickened, peeling, cracked, painful, and/or red skin.
MRI: Magnetic resonance imaging.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
PROGRESSION: An increase in total tumor measurements by at least 20% compared to when the patient started taking a drug; or the appearance of a new tumor (metastasis) related to the cancer for which the patient was being treated.
PROGRESSION-FREE SURVIVAL: The length of time during which 1) the patient’s cancer does not meet the definition of “progression” (see above) AND 2) the patient remains alive.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

FOTIVDA Prescribing Information

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