AUCATZYL offers the possibility for
lasting remission
AUCATZYL was tested in people who either had B‑cell acute lymphoblastic leukemia (B‑ALL) return after a previous treatment, or who were not helped by their last treatment.
Among 65 people treated with AUCATZYL in the clinical study
4 in 10
had a complete remission within 3 months
(27 out of 65 people)
had a complete remission at any time
(33 out of 65 people)
6 in 10
had an overall complete remission at any time
(41 out of 65 people)
Complete remission means the percentage of leukemia cells in the body is below 5% and there are no more signs and symptoms of B‑ALL.
Overall complete remission means the percentage of leukemia cells in the body is below 5% and there are no more signs and symptoms of B‑ALL, but some blood tests are still not completely normal.
Half of patients who had a complete remission within 3 months were
leukemia‑free for over 14 months*Some remained in remission for nearly 2 years†
*Fourteen months was the median duration of complete remission, which means 50% of responding patients in the study were in remission for less than 14 months, and 50% were in remission for longer than 14 months.
†The time in remission for people in the study who had complete remission was different for everyone and ranged from less than a month to 21 months. Some people were still in remission at the end of the study.
What are some potential side effects?
AUCATZYL‘s unique dosing was designed to help limit potential side effects and to help your doctor manage them if they should occur. However, side effects that are life-threatening and can lead to death may occur after treatment.
Potential side effects
with AUCATZYL
Call or see your healthcare provider or get emergency help right away if you get any of the following potentially serious side effects:
- Fever (100.4°F/38°C or higher)
- Severe nausea, vomiting, diarrhea
- Severe headache
- Dizziness or lightheadedness
- Difficulty breathing
- Confusion
- Fast or irregular heartbeat
- Low blood pressure
- Chills/shivering
- Shaking or twitching (tremor)
The most common side effects of AUCATZYL include:
- Fever (100.4°F/38°C or higher)
- Nausea
- Diarrhea
- Infections
- Headache
- Muscle or joint pain
- Fatigue or feeling very tired
- Low blood pressure (dizziness or lightheadedness, headache, fatigue, short of breath)
- Fast irregular heartbeat
- Confusion
- Difficulty speaking or slurred speech
- Low white blood cells (can occur with a fever)
- Bleeding
AUCATZYL may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this.
Cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS) are two serious side effects that are common with CAR T‑cell therapies, including AUCATZYL.
Percentage of people who experienced severe CRS or ICANS in the study
3%
(3 out of 100 people)
75%
(75 out of 100 people)
7%
(7 out of 100 people)
24%
(24 out of 100 people)
These are not all the possible side effects of AUCATZYL. Everyone responds differently to treatment, so it’s important to communicate openly with your healthcare team. Call your healthcare provider about any side effects that concern you. You may report side effects to FDA at 1-800-FDA-1088.
Made from your cells,
dosed for your needs
The personalized treatment process of AUCATZYL goes beyond just working with your immune cells—your dose is also geared to you. AUCATZYL is the first CAR T‑cell therapy for relapsed and refractory B‑ALL that uses 2‑part dosing that’s based on the level of leukemia in your body.
A one‑time treatment delivered in 2 customized doses:
Dose 1
Your doctor will determine your first dose based on your bone marrow assessment.
Dose 2
About 10 days after your first dose, you’ll receive the remainder of your total dose. Everyone treated with AUCATZYL receives the same total dose.
This unique dosing allows your doctor to adjust the amount and timing of treatment, which may help reduce the risk of side effects while giving you the power you need to fight B‑ALL.
Get the facts about AUCATZYL in one easy guide.
Download the brochure.
6 key steps in the
treatment journey
Once you and your doctor decide AUCATZYL is right for you, your treatment team will:
1. Collect your cells
Your blood will be drawn through a process called leukapheresis. This separates out certain immune cells, including T cells. The rest of your blood is returned to your body.
2. Send your cells to be made into AUCATZYL
These collected T cells are sent to a specialized lab, where anti-cancer receptors called CARs are attached to make your customized AUCATZYL treatment. Your doctor may give you another treatment to help stabilize your cancer while your AUCATZYL is being made.
3. Determine your customized dose
A bone marrow test will let your doctor know your leukemia level so they can plan your AUCATZYL dose schedule.
4. Prepare your body to receive AUCATZYL
Within 7 days after your bone marrow test, your doctor will give you chemotherapy for 4 days to make room for AUCATZYL CAR T cells.
5. Administer AUCATZYL
Your first AUCATZYL dose is given as an infusion 3 days after chemotherapy is finished. You’ll receive your second dose about 10 days later.
6. Monitor your progress
Your team will monitor you for at least 2 weeks after each infusion and will manage any side effects that may occur.
Want to learn more about the AUCATZYL process?
Download the guide.
AUCATZYL may be given either in the hospital (inpatient) or in the outpatient setting. Your doctor will
review your options for where and how you’ll be treated and monitored.
- CAR=chimeric antigen receptor.