DAN’S STORY OF HOPE—VIDEO TRANSCRIPT

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[Breyanzi logo]

[text on screen] BREYANZI® (lisocabtagene maraleucel) suspension for IV infusion is a prescription medicine used to treat large B cell lymphoma, a type of non-Hodgkin lymphoma, when:

  • your first treatment has not worked or your cancer returned within a year of your first treatment OR 
  • your first treatment has not worked or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age OR 
  • two or more kinds of treatment have not worked or stopped working.

BREYANZI is different than other cancer medicines because it is made from your own white blood cells, which have been genetically modified to recognize and attack your lymphoma cells.

BREYANZI® may cause side effects that are life-threatening and can lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

Please see Important Safety Information, including the Boxed WARNINGS toward the end of this video.

Dan’s story

Actual Patient

[Visual Description: There is a rope on a pier. Dan is steering his boat. Cut to Dan standing on the pier looking out.]

[Dan speaking] I was headed for retirement and my retirement was going to buy a boat, and I was going to live on it. When I stopped looking at boats, I think that's when she got nervous.

[text on screen] It started with a lump in the neck.

[Visual Description: Dan is sitting in a room with his wife, Jodi.]

[Dan speaking] My primary found a lump on my neck, which they biopsied, and then it was non-Hodgkin’s lymphoma. And we decided we’d do watchful waiting. And there were no symptoms, there was nothing. I just went and got a scan every now and then and did some blood work. And then for three years, I started to get sick: shortness of breath, tired.

[Visual Description: Jodi is taking a sip out of her mug as she sits next to Dan.]

[Jodi speaking] At its worst, he was capable of getting up and going to the bathroom and then he'd go back to bed. It was the day before Thanksgiving. The oncologist called and said, “You have diffuse large B-cell lymphoma and need chemo. Have a happy Thanksgiving.” He'd had a scan after about, probably about four or five weeks, they said, “The cancer is growing. There is no need to continue these treatments.”

[Visual Description: Dan walks on a pier.]

[Dan speaking] My oncologist said, “We don't have anything here, but I have a friend at the other hospital that has a bunch of trials going on, and we think that possibly he can help you.”

[text on screen] Dan’s cancer was unresponsive to 2 prior lines of treatment and continued to spread.

Dan discussed treatment options with his oncologist, and decided to join a BREYANZI® clinical study.

[Visual Description: Dan continues walking. Then Dan is sitting next to Jodi and speaking to camera.]

[Dan speaking] The doctor, he was fantastic. He spent the two hours with us. He went through everything, he asked us what we thought, how we felt, and the CAR T-cell therapy was one of the first ones on his list, and it just sounded really good to me.

[Jodi speaking] He introduced what turned out to be Breyanzi CAR T-cell therapy.

[text on screen] Individual results may vary.

[Visual Description: There are images of Dan in the hospital receiving an infusion. Then Dan sitting next to Jodi and speaking to camera. Later Dan and Jodi are outside with their family. Dan and Jodi are then speaking to camera again.]

[Dan speaking] With the CAR T, they did the infusion. The nurse came in and there was a white board in the room, and she wrote on the board: This is your day one. And the whole time I was there, they were coming in every day, and they would change that to two, to three, you know? At that point, there was a lot of hope. The next day, it started to sink in that this was probably really going to work because I could start to do things again. Not that it was much, but it was the start, and it was more than I've been doing.

[Jodi speaking] By the end of this hospital stay, we were walking laps around the whole unit.

[Visual Description: Dan and Jodi are walking down a street.]

[Dan speaking] I had a good experience with Breyanzi. They monitored me for side effects, blood pressure, temperature, and all that.

[Jodi speaking] They were looking for neurotoxicity and other side effects.

[Visual Description: Dan and Jodi are walking across a bridge. Then Dan and Jodi are sitting on the couch and speaking to the camera.]

[Dan speaking] With the exception of an elevated temperature, everything went really well for me. And I’m sure everybody's different.

[text on screen and VO] We will hear more from Dan after this brief important safety information.

[text on screen and VO] BREYANZI® can cause side effects that may be life threatening and can lead to death, such as cytokine release syndrome, and neurologic toxicities. Due to the risk of cytokine release syndrome, neurologic toxicity, and other side effects, patients must remain at or close to where they received treatment for at least 4 weeks after the infusion for side-effect monitoring.

The most common side effects of BREYANZI are fatigue, difficulty breathing, fever, chills, shaking chills, confusion, difficulty speaking or slurred speech, severe nausea, vomiting, diarrhea, headache, dizziness, lightheadedness, fast or irregular heartbeat, and swelling.

These are not all the possible side effects of BREYANZI and can vary from patient to patient. Call your doctor for medical advice about side effects.

A few weeks after BREYANZI® infusion, Dan went back for a follow-up with his oncologist.

Individual results may vary. While the scans showed that Dan was in remission, they do not mean he’s cancer-free. Dan continues to be monitored for possible disease recurrence and long-term side effects from Breyanzi®.

[Visual Description: Dan and Jodi are walking on a pier. Then Dan and Jodi are speaking to camera.]

[Dan’s speaking] They put up two scans on the board, and in the scan, the cancer like shows up as a light. My 30 day I go to scan, my whole abdomen and halfway up my back was just a bright light, and the one they took that morning? Just black.

[Jodi’s speaking] To see that difference on the screen was remarkable, and I was crying. The nurse practitioner who took care of him was crying. The doctor was beaming, and everybody looked at him and he said, “Wow, no wonder I didn't feel good.” That was his response. But then, so that was, that must have been October, beginning of October, and by January he bought a boat.

[text on screen] Breyanzi® was approved for the treatment of large B-cell lymphoma in people whose first treatment has stopped working or did not work within one year, including in patients who are not eligible for stem cell transplant because of medical conditions or age.

[Dan’s speaking] You realize how short life can be and how lucky you are, and, you really, there's no reason to put things on hold.

[Jodi’s speaking] Yes. We're lucky.

[Breyanzi logo]

[text on screen and VO]

Indications

BREYANZI® is a prescription medicine used to treat a type of non-Hodgkin lymphoma:

  • Large B cell lymphoma, when:
    • your first treatment has not worked or your cancer returned within a year of your first treatment, OR 
    • your first treatment has not worked or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age, OR 
    • two or more kinds of treatment have not worked or stopped working.

BREYANZI is different than other cancer medicines because it is made from your own white blood cells, which have been genetically modified to recognize and attack your lymphoma cells.

Important Safety Information

What is the most important information I should know about BREYANZI?

BREYANZI may cause side effects that are life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:

  • difficulty breathing 
  • fever (100.4°F/38°C or higher) 
  • chills/shaking chills 
  • confusion 
  • severe nausea, vomiting, diarrhea 
  • fast or irregular heartbeat 
  • dizziness/lightheadedness 
  • severe fatigue or weakness

It is important that you tell your healthcare providers that you have received BREYANZI and to show them your BREYANZI Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

Before getting BREYANZI, tell your healthcare provider about all your medical problems, including if you have or have had:

  • Neurologic problems (such as seizures, stroke, or memory loss) 
  • Lung or breathing problems 
  • Heart problems 
  • Liver problems 
  • Kidney problems
  • A recent or active infection

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive BREYANZI?

  • BREYANZI is made from your own white blood cells, so your blood will be collected by a process called leukapheresis. 
  • It takes about 3-4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary. 
  • Before you get BREYANZI, you will get 3 days of chemotherapy to prepare your body. 
  • When your BREYANZI is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). BREYANZI is given as infusions of 2 different cell types. 
    • You will receive infusions of one cell type, immediately followed by the other cell type. 
    • The time for infusion will vary but will usually be less than 15 minutes for each of the 2 cell types. 
  • During the first week after infusion, you will be monitored daily by the facility where you received your treatment. 
  • You should plan to stay within 2 hours of the location where you received your treatment for at least 4 weeks after getting BREYANZI. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur. 
  • You may be hospitalized for side effects. Your healthcare provider will discharge you if your side effects are under control, and it is safe for you to leave the hospital. 
  • Your healthcare provider will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving BREYANZI?

  • Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get BREYANZI. This is because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, dizziness, and seizures. 
  • Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of BREYANZI?

The most common side effects of BREYANZI are:

  • fatigue 
  • difficulty breathing 
  • fever (100.4°F/38°C or higher) 
  • chills/shaking chills 
  • confusion 
  • difficulty speaking or slurred speech 
  • severe nausea, vomiting, diarrhea 
  • headache 
  • dizziness/lightheadedness 
  • fast or irregular heartbeat
  • swelling 
  • low blood pressure 
  • muscle pain

BREYANZI can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

BREYANZI can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.

BREYANZI may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

Having BREYANZI in your blood may cause a false-positive HIV test result by some commercial tests.

These are not all the possible side effects of BREYANZI. Call your doctor for medical advice about side effects. For more information, go to BREYANZI.com or call 1-888-805-4555. You may report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

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BREYANZI and the related logo are trademarks of Juno Therapeutics, Inc., a Bristol Myers Squibb company.



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