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Kymriah bla. KYMRIAH® (Tisagenlecleucel) is a CD19-directed genetically modified autologous T Sep 19, 2018 · Kymriah is a type of advanced therapy medicine called a ‘gene therapy product’. Find resources for acute lymphoblastic leukemia (ALL) support groups and communities for children, young adults, and caregivers. market following FDA approval yesterday. T cell sare special cells in your body that are naturally designed to attack cancer. Aug 31, 2017 · August 31, 2017. U. ) a CD19-directed genetically modified autologous T-cell immunotherapy Proprietary Name: KYMRIAH. Severe nausea, vomiting, diarrhea. The generic name of Kymriah is tisagenlecleucel. Treatment Center Support. Kymriah cell-based gene therapy relapsed and refractory DLBCL 2018 Novartis Pharmaceuticals B cell precursor ALL 2017 Luxturna non-cell-based gene therapy retinal disease 2017 Spark Therapeutics Yescarta cell-based gene therapy large B cell lymphoma 2017 Kite, a Gilead Company Maci tissue-engineered producr cartilage diseases 2016 Vericel To learn more, please call KYMRIAH CARES at 1-844-4KYMRIAH ( 1-844-459-6742) from 8:00 AM to 8:00 PM ET. Serious side effects occur in most patients. Proper Name: tisagenlecleucel. PDUFA Goal Date . This is a type of medicine that works by delivering genes into the body. Now, the new finalized guidance recommends routinely rolling out Kymriah and removing it from the Cancer Drugs Fund accordingly. Credit: Novartis. APPROVAL . Proprietary Name: KYMRIAH. 1 to 2. Lijek Kymriah primjenjuje se za liječenje rijetkih vrsta raka krvi te je status lijeka za rijetku bolest za liječenje ALL-a B-stanica dobio 29. Dec 31, 2023 · Kymriah® (tisagenlecleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, is currently approved in major markets for the treatment of relapsed/refractory (r/r) pediatric and young adult acute lymphoblastic leukemia, r/r diffuse large B-cell lymphoma, and r/r follicular lymphoma. (1) T or NK cells are isolated from the patient’s or donor’s blood. a) Product Quality KYMRIAH CMC was reviewed and approved in the initial BLA submission, 125646/0. KYMRIAH ® (tisagenlecleucel) was originally studied in a global clinical trial of children and young adults with relapsed or refractory B-cell ALL, with many achieving an early and lasting remission. Novartis’ Kymriah (tisagenlecleucel) will be the first chimeric antigen receptor T-cell (CAR-T) cancer immunotherapy to reach the U. Provides access to resources for patients such as financial assistance, patient support programs, information May 31, 2022 · U. May 27, 2022 Whether you have questions about KYMRIAH ® (tisagenlecleucel), need assistance locating a KYMRIAH Certified Treatment Center, or have questions regarding patient assistance programs, KYMRIAH CARES is here to help. You do not need to be in complete remission to receive KYMRIAH. 5 x 108 CAR-positive viable T cells for patients more KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising Jun 2, 2021 · Kymriah also has Orphan Drug designation from the FDA for this disease. fda. About Kymriah Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. The emergence of cell and gene therapies has dramatically changed the treatment paradigm in oncology and other therapeutic areas. - 12 mg/kg if body weight < 30 kg. Pero también será Based on the safety and efficacy observed in Phase 1 and 2 studies, Novartis and Kite have developed quite different dosing recommendations. Patient Support. Sep 3, 2017 · The Food and Drug Administration’s approval of Kymriah was met with excitement for its potential—as well as concerns about the $475,000 cost of this breakthrough gene therapy treatment for a . Aug 30, 2017 · The FDA accepted Novartis’ Biologics License Application (BLA) for Kymriah, filed in March 2017, for Priority Review—under which FDA set a goal of taking action on Novartis’ CAR T-cell Kymriah demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of data cut-off, indicating sustainability of response1Kymriah is the only CAR-T therapy FDA-approved for two distinct indications - in non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia (ALL)Novartis has established leadership based on first-to-launch CAR-T supplement your Biologics License Application (BLA) under section 351(a) of the Public June 11, 2021 Approval Letter - KYMRIAH Created Date: 6/14/2021 8:58:41 AM KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell May 28, 2022 · Kymriah can be administered in the outpatient setting, offering increased flexibility and potentially reducing the burden of therapy for patients and their care teams 1,2; Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings 1 Understanding KYMRIAH. Credit: LindseyRN / Shutterstock. obecabtagene autoleucel (obe-cel) Autolus’ lead product candidate is a CD19 chimeric antigen receptor T cell therapy (CAR-T). Advances that improve the reproducibility of CAR T cells expansion and KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Fever (100. Find a KYMRIAH Treatment Center. May 27, 2022 · 68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile1Sustained clinical benefit from Kymriah treatment demonstrated – of patients who achieved a complete response, 85% were still in response at 12 months1 Kymriah can be administered in the outpatient setting, offering increased KYMRIAH ® is a cutting-edge immune based cellular therapy that uses your child's own immune system to treat their cancer. KYMRIAH is shipped directly to the cell lab associated with the infusion center in a liquid nitrogen Dewar. Important Safety Information for KYMRIAH® (tisagenlecleucel) Download helpful materials for KYMRIAH, including a guide for patients and caregivers. One of the benefits of CAR-T cell Most side effects happen in the weeks following infusion with KYMRIAH. 4°F/38°C or higher) Chills/shaking chills. KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. 1: Schematic illustration of a CAR-T or CAR-NK cell therapy, which uses primary immune cells. seeks approval of Stelara® (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn’s Disease. Tradename: KYMRIAH. 125746/663 . Patel: Please refer to your Biologics License Application (BLA) for tisagenlecleucel dated February 2, 2017, received February 2, 2017, submitted under section 351(a) of Call your health care provider or get emergency help right away if you get any of the following signs and symptoms of: Cytokine Release Syndrome: Difficulty breathing. Kymriah, previously known as CTL019, is indicated for the treatment of second or later relapsed or refractory (r/r) patients up to age 25 with B-cell Jul 7, 2022 · BLA efficacy supplement . 5 months when they received Amgen's bispecific T-cell engager Blincyto (blinatumomab) or 3 months when they received salvage chemotherapy. listopada 2016. Nov 25, 2015 · Janssen Biotech Inc. Call your health care provider or get emergency help right away if you get any of the following: Difficulty breathing. The NDC code 0078-0846 is assigned by the FDA to the product Kymriah which is a cellular therapy product labeled by Novartis Pharmaceuticals Corporation. A KYMRIAH dose may be contained in one to three cryopreserved patient specific infusion bag(s). What is KYMRIAH? KYMRIAH is made from your own white blood cells and is a prescription cancer treatment used in patients up to 25 years of age who have acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or is refractory (did not go into remission after receiving other leukemia treatments). “CAR-T therapy represents a significant breakthrough in the treatment of leukemia that has not responded to traditional therapies,” says Jeffrey Dome, M KYMRIAH therapy is available at select treatment centers across the United States. B2202 is a multicenter, open-label BLA: STN 125646 Regulatory Milestone: KYMRIAH Kersten Compliance Services, LLC 2 04/12/2017 Breakthrough Therapy Designation for DLBCL 08/04/2017 Pre-sBLA meeting KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Stelara® BLA was submitted under the 505(b)(1) pathway. August 27, 2021 . KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. S. ¹This use is approved under FDA’s Accelerated Approval Program. KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. KYMRIAH is different from a stem cell transplant (SCT). gov Our STN: BL 125646/663 SUPPLEMENT . First, your child's doctor will take some of your child's blood to collect their T cells. Important Safety Information for KYMRIAH® (tisagenlecleucel) Cytokine release syndrome (CRS Aug 1, 2023 · Administer tocilizumab c intravenously over 1 hour: - 8 mg/kg (max. Oct 16, 2019 · Kymriah became one of the first European Union–approved CAR T therapies. Discover how KYMRIAH works, what makes it different from other therapies, and whether it could be right for you. Manufacturer: Novartis Pharmaceuticals Corporation. CAR-T is made up of your own T cells that have been reprogrammed to better detect and destroy cancerous (and normal) B cells in the body. KYMRIAH ® (tisagenlecleucel) is a type of immunotherapy for patients with relapsed or refractory (r/r) B-cell ALL. travnja 2014. , za liječenje DLBCL-a 14. Kymriah dose for adults with NHL is 60 to 600 x 106 cells flat dose if weight is >50kg. BLA efficacy supplement . Kymriah became one of the first European Union-approved CAR T therapies. Whether you have questions about KYMRIAH ® (tisagenlecleucel), treatment center locations, or insurance coverage, KYMRIAH CARES is here to help. Discuss your treatment history and overall health with your doctor to see if you are a candidate for KYMRIAH therapy. Apr 25, 2024 · STN: 125646. Unlike traditional chemotherapy or allogenic stem cell transplant, CAR-T is a type of immunotherapy, called CAR-T cell therapy or chimeric antigen receptor T cell therapy. Feb 28, 2018 · KYMRIAH CMC was reviewed and approved in the initial BLA submission, 125646/0. Protocol Assessment, provided the basis for the BLA submission for a regular approval for KYMRIAH. Apr 16, 2019 · Kymriah marks a new era of cancer treatment and the pediatric indication for it paves the way for the use of similar therapies with promise to treat other deadly cancers affecting children. Kymriah sadrži djelatnu tvar tisagenlekleucel (koji se sastoji od genetički izmijenjenih bijelih krvnih KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. STN . single dose of KYMRIAH contains 0. supplement your Biologics License Application (BLA) under section 351(a) of the Public June 11, 2021 Approval Letter - KYMRIAH Created Date: 6/14/2021 8:58:41 AM It is important to know who is on your KYMRIAH treatment team and how to get in touch with them. B2202 is a multicenter, open-label Tisagenlecleucel is only available as part of a special program called Kymriah REMS (Risk Evaluation and Mitigation Strategies). Indication: KYMRIAH is a CD19-directed genetically modified autologous T-cell Aug 30, 2017 · Kymriah is a genetically-modified autologous T-cell immunotherapy. Aug 31, 2017 · La terapia, aprobada por primera vez en Estados Unidos, modifica las células del paciente para que éstas ataquen el cáncer y ha demostrado ser "increíblemente efectiva". This indication is approved under accelerated approval based on response rate and duration of response. Mar 22, 2021 · Fig. The chimeric antigen Jun 12, 2022 · For the 79 patients treated with Kymriah in this study, the five-year overall survival (OS) rate was 55% (95% CI, 43-66), while the median event-free survival (EFS) for patients in remission KYMRIAH ® (tisagenlecleucel) may cause side effects that are severe or life-threatening. Yescarta dose for NHL is 2 × 106 cells/kg. The Biologics License Application (BLA) in patients with KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Product and patient-specific labels are located inside the Dewar. KYMRIAH® (Tisagenlecleucel) is a CD19-directed genetically modified autologous T Jun 22, 2022 · Kymriah™ (tisagenlecleucel) is indicated for the treatment of acute lymphoblastic leukaemia (ALL), B-cell lymphoma, and follicular lymphoma. Find out how Kymriah, a type of CART cell therapy, works in patients with relapsed/refractory follicular lymphoma. Kymriah® (tisagenlecleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, is currently approved in major markets for the treatment of relapsed/refractory (r/r) pediatric and young adult acute lymphoblastic leukemia, r/r diffuse Jan 31, 2018 · Tisagenlecleucel (formerly CTL019), an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, is under investigation in patients with relapsed or refractory B-cell cancers, including B-cell Linkedin. The new approval of tisagenlecleucel is for lymphoma—specifically DLBCL, high-grade B-cell lymphoma, and DLBCL that arises from follicular lymphoma— that has come back or gotten August 30, 2017. Kymriah is indicated for the treatment of: Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is KYMRIAH ® (tisagenlecleucel) is a treatment used in patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL), that has relapsed or is refractory after having at least 2 other kinds of treatment. On May 1, 2018, the Food and Drug Administration approved tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp. Dec 20, 2022 · 09/30/2022. Novartis confirmed to this publication it has responded to KYMRIAH is a therapy for children and young adults up to 25 years of age with B-cell ALL that is refractory or in second or later relapse. 800 mg) if body weight ≥ 30 kg. Kymriah is a chimeric antigen receptor T-cell (CAR-T) therapy. As a condition of approval, a confirmatory trial(s) must show that tisagenlecleucel provides a clinical benefit in these patients. The product is distributed in a single package On May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory Dec 1, 2018 · Patients with diffuse large B-cell lymphoma that is refractory to primary and second-line therapies or that has relapsed after stem-cell transplantation have a poor prognosis. Please call KYMRIAH CARES ™ at 1‑844‑4KYMRIAH ( 1-844-459-6742) for more information about KYMRIAH Treatment Centers, the ordering process, product information, and patient support. Indication. It happens in three stages: Collection. ALL is a type of cancer that is caused by the uncontrolled growth of white blood cells. Consequently, module 3 (Quality) was not included in Amendment 76, and no facility review/inspections are required. To learn more, please call KYMRIAH CARES at ( 1-844-459-6742) from 8:00 AM to 8:00 PM ET. Go to What should I ask my treatment team? for help speaking with your doctor. The blood cancers that Kymriah is used to treat are rare, and Kymriah was designated an ‘orphan medicine’ (a medicine used in rare diseases) for B-cell ALL on 29 April 2014, DLBCL on 14 BLA Clinical Review Memorandum Application Type Original Application STN 125646 Kymriah is a genetically modified autologous immunocellular therapy indicated for the Jan 22, 2019 · The Clinical Program study B2202 (ELIANA, NCT02228096) 16 provided the basis for the biologics license application (BLA) submission for a regular approval for KYMRIAH 17. See full Prescribing & Safety Info, including Boxed WARNING KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. To learn more, please call KYMRIAH CARES at 1-844-459-6742 from 8:00 AM to 8:00 PM ET. To expand the indication to include routine prophylaxis to reduce the frequency of bleeding episodes in adults and children Tisagenlecleucel was the first CAR T-cell therapy to receive FDA approval. REBINYN Coagulation Factor IX (Recombinant) GlycoPEGylated. 5 x 108 CAR-positive viable T cells for patients more single dose of KYMRIAH contains 0. 0 x 106 CAR-positive viable T cells per kg of body weight for patients 50 kg or less, or 0. Jan 19, 2021 · Kymriah obtained breakthrough designation for the following indications: treatment of adult patients with diffuse large B-cell lymphoma and treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse. Feb 6, 2024 · Autolus. 1 May 27, 2022 · 68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile 1; Sustained clinical benefit from May 15, 2023 · ABSTRACT. Kymriah is a genetically modified autologous immunocellular therapy indicated for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body's own T cells to fight cancer (adoptive cell transfer). i za liječenje FL-a 19. B2202 evaluated the safety and effectiveness for the treatment of pediatric and young adult patients with second or later relapse or primary refractory B-cell precursor acute Jun 1, 2022 · Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of B-cell acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and follicular lymphoma (FL). Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www. It was approved in 2017 for the treatment of children and young adults with leukemia. Ask your doctor for a KYMRIAH Patient Binder to help you keep track of important information such as appointments, business cards, emergency numbers, email addresses, and notes from your discussions with your medical team. Apr 11, 2024 · Patients lived for a median of four years after receiving Kymriah versus 7. Get help immediately if you experience any of the following: Difficulty breathing. Coordinate the timing of thaw of KYMRIAH and infusion in the following manner. (2) Subsequently, cells FOR KYMRIAH: Pages 12-13 SAMPLE LETTERS: Page 13 KYMRIAH CARES™ SUMMARY OF SUPPORT RESOURCES: Last Page 6 5 11 4 10 8 3 9 7 2 1 This guide provides general coding and billing information to assist you with understanding the reimbursement of KYMRIAH® (tisagenlecleucel) following administration at one of the KYMRIAH Treatment Centers. See full Prescribing & Safety Info, including Boxed WARNING. Very low blood pressure. The active substance of Kymriah is tisagenlecleucel, an autologous, immunocellular cancer therapy that involves reprogramming the patient's own T cells to identify and eliminate CD19‐expressing cells. Feb 27, 2023 · An empirical, non-linear mixed-effects model was developed to quantify the pharmacokinetics of Kymriah (tisagenlecleul, CTL019) 5 and provided as part of the biologics license application (BLA) 4. Important Safety Information for KYMRIAH® (tisagenlecleucel) KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Confirm the infusion time in advance, and adjust the start time for thaw so that Oct 31, 2017 · Basel, October 31, 2017 - Novartis today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah TM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible Dec 7, 2023 · In 2017, Kymriah became the first CAR-T therapy approved in the US and last year brought in $536 million in revenues for Novartis. Provides product-specific support, including managing and coordinating your orders related to KYMRIAH. Apr 12, 2024 · KYMRIAH is supplied as a frozen suspension of genetically modified autologous T cells in an infusion bag(s) labeled for the specific recipient. Ped ALL: NDC 0078-0846-19 KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Limitation of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. 2 to 5. Verify the number of bags received for the dose of KYMRIAH with the Certificate of Conformance (CoC) and Certificate of Analysis (CoA). May 1, 2018 · Kymriah, developed in collaboration with the University of Pennsylvania, became the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. KYMRIAH ® (tisagenlecleucel) is a treatment used in adult patients with follicular lymphoma (FL), a type of non-Hodgkin lymphoma, that has relapsed (went into remission, then came back) or is refractory (did not go into remission after receiving other lymphoma treatments) after having at least two other kinds of treatment. Your treatment team knows what to expect and is prepared to help manage these side effects. The FDA requested Novartis to respond to its letter within 30 days outlining specific steps taken or planned to be taken to correct the noted deviations. CBER Received Date . Delay KYMRIAH infusion after lymphodepleting chemotherapy if patient has unresolved serious adverse reactions from preceding chemotherapies, active uncontrolled infection, active graft vs host disease, or worsening of leukemia burden. The active substance of Kymriah is tisagenlecleucel, an autologous, immunocellular cancer therapy that involves reprogramming the patient's own T cells to identify and eliminate CD19-expressing cells. srpnja 2021. Dear Dr. Food and Drug Administration KYMRIAH® (tisagenlecleucel) is made from your own white blood cells and is a prescription cancer treatment used in patients up to 25 years of age who have acute lymphoblastic leukemia (ALL) that has relapsed (went into remission, then came back) or is refractory (did not go into remission with other leukemia treatments). Severe muscle or joint pain. This is achieved by addition of a transgene encoding a CAR. This educational module contains information on selected KYMRIAH-associated adverse events, including cytokine release syndrome and neurological toxicities, observed in clinical trials ELIANA, JULIET, and ELARA for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse, adult patients with relapsed or refractory There are side effects you may experience with KYMRIAH ® (tisagenlecleucel) therapy. It is a one-time treatment designed to empower patients’ immune systems to fight their cancer. The product's dosage form is injection, suspension and is administered via intravenous form. Dec 7, 2023 · In fact, between late 2018 and the 2022 inspection, the FDA says Novartis flagged 100 batches of Kymriah that were contaminated with foreign particulates such as wood, cellulose, brass and steel. The product used in these clinical studies under Protocol C2201 conforms with the product used in the initial submission. Confusion. Stelara® was approved for the treatment of adults with moderate to severe plague psoriasis and/or active psoriatic arthritis (PsA) in the United States under BLA 125261 on September 25 KYMRIAH® (tisagenlecleucel) is made from your own white blood cells and is a prescription cancer treatment used in patients with large B-cell lymphoma, a type of non-Hodgkin lymphoma, that has relapsed (went into remission, then came back) or is refractory (did not go into remission after receiving other lymphoma treatments) after having at least two other kinds of treatment. If no improvement after first dose, repeat every 8 hours (limit to a maximum of 3 dosages in 24 hours period; maximum total of 4 doses). en ov az wj gh zn fv ex vm kv