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Further information is available at m or kite (5483). Hypersensitivity reactions Allergic reactions may occur with the infusion of Yescarta. Serious hypersensitivity reactions including anaphylaxis, may be due to dimethyl sulfoxide (dmso) or residual gentamicin in Yescarta. Serious Infections severe or life-threatening infections occurred in patients after Yescarta infusion. In Study 1, infections (all grades) occurred in 38 of patients. Grade 3 or higher infections occurred in 23 of patients. Grade 3 or higher infections with an unspecified pathogen occurred in 16 of patients, bacterial infections in 9, and viral infections. Yescarta should not be administered to patients with clinically significant active systemic infections.

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Grade 3 or higher neurologic toxicities occurred in 31 of patients. The most common neurologic toxicities included encephalopathy (57 headache (44 tremor (31 dizziness (21 aphasia (18 delirium (17 insomnia (9) and anxiety (9). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta. Fatal and serious cases of cerebral edema have occurred in patients treated with Yescarta. Monitor patients at least daily for between 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly. Because of the risk of crs and neurologic toxicities, yescarta is available only through a restricted program under a risk evaluation and Mitigation Strategy (rems) called the yescarta rems. The required components of the yescarta rems are: healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the rems requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of crs. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta are trained about the management of crs and neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to infusion of Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of crs. Monitor patients for signs or symptoms of crs for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of crs occur at any time. At the first sign of crs, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated. Neurologic Toxicities, neurologic toxicities, that were fatal or life-threatening, occurred following treatment with Yescarta. Neurologic toxicities occurred in 87 of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks of Yescarta infusion, with a median time to onset of 4 days (range: 1 essay to 43 days). The median duration of neurologic toxicities was 17 days.

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Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed. Yescarta is available only through a restricted program under a risk evaluation and Mitigation Strategy (rems) called the yescarta rems. Cytokine release syndrome (crs crs, including fatal or life-threatening reactions, occurred following treatment with Yescarta. In Study 1, crs occurred in 94 (101/108) of patients receiving Yescarta, including Grade 3 (lee grading system) crs in 13 (14/108) of patients. Among patients who died after receiving Yescarta, four had ongoing crs events at the time of death. The median time to onset was 2 days (range: 1 to 12 days) and the median duration of crs was 7 days (range: 2 to 58 days). Key manifestations of crs include fever (78 hypotension (41 tachycardia (28 hypoxia (22 and chills (20). Serious events that may be associated with crs include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

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In this study, business 72 percent of patients treated with a single infusion of Yescarta (n101) responded to therapy (overall response rate) including 51 percent of patients who had no detectable cancer remaining (complete remission; 95 CI: 41, 62). At a median follow-up.9 months, patients who had achieved a complete remission had not reached the estimated median duration of response (95 CI:.1 months, not estimable ne). In the study, 13 percent of patients experienced grade 3 or higher cytokine release syndrome (CRS) and 31 percent experienced neurologic toxicities. The most common ( 10) Grade 3 or higher reactions include febrile neutropenia, fever, crs, encephalopathy, infections-pathogen unspecified, hypotension, hypoxia and lung infections. Serious adverse reactions occurred in 52 of patients and included crs, neurologic toxicity, prolonged cytopenias (including neutropenia, thrombocytopenia and anemia and serious infections. Fatal cases of crs and neurologic toxicity occurred. Fda approved Yescarta with a risk evaluation and Mitigation Strategy.

Yescarta Indication, yescarta is a cd19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large biography b-cell lymphoma after two or more lines of systemic therapy, including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, primary mediastinal. Important safety information, boxed, warning: cytokine release syndrome and neurologic toxicities. Cytokine release syndrome (crs including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening crs with tocilizumab or tocilizumab and corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with crs or after crs resolution.

This support is designed to assure the safe and effective use of Yescarta for patients and physicians. Kite is actively working to train more than 30 additional centers with an eventual target of 70 to 90 centers across the United States. The latest information on Yescarta authorized centers is available. In support of Yescarta therapy, kite has developed Kite konnect, a program enabled by an integrated technology platform that focuses on providing information and assistance throughout the yescarta therapy process, including courier tracking for shipments and manufacturing status updates. Kite konnect also will provide information related to insurance benefits and third-party resources available for travel support.

Healthcare providers and patients can reach Kite konnect at m or kite ( ). The list price of Yescarta in the United States is 373,000. Yescarta has been granted Priority medicines (prime) regulatory support for dlbcl in the european Union. A marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the european Medicines Agency (EMA) and potential approval is expected in the first half of 2018. Yescarta (axicabtagene ciloleucel) pivotal Trial Results. The approval of Yescarta is supported by data from the zuma-1 pivotal trial.

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Early on, lls recognized the potential of car t therapy and we are proud to be part of making this historic approval possible. Engineered cell therapies like yescarta represent the potential for a changing treatment paradigm for cancer patients, said david Chang, md, phd, worldwide head of Research and development and Chief Medical Officer at Kite. Together, gilead and Kite will accelerate studies of car t therapy in multiple resumes blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy. Yescarta will be manufactured in Kites state-of-the-art short commercial manufacturing facility in El Segundo, california. In the zuma-1 pivotal trial, kite demonstrated a 99 percent manufacturing success rate with a median manufacturing turnaround time of 17 days, which is important to patients given the potential for rapid disease progression in this population. In 2017, kite established a multi-disciplinary field team focused on providing education and logistics training for centers. Upon Yescartas approval, this team will provide final site certification to 16 centers, enabling them to make yescarta available to appropriate patients.

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Currently, patients with large b-cell lymphoma in second or later lines of therapy have poor life outcomes and greater unmet need, since nearly half of them either do not respond or relapse shortly after transplant. With car t therapy, we are reengineering a patients own immune system to detect and kill cancer cells, and the results have been impressive, said Frederick. Locke, md, zuma-1 co-lead Investigator and Vice Chair of the department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, florida. Many of the patients that received car t therapy had already relapsed several times with traditional treatments such as chemotherapy or hematopoietic stem cell transplant. Now, thanks to this new therapy many patients are in remission for months. This therapy is a new option for patients with relapsed or refractory large b-cell lymphoma who have run out of treatment options and face a dire prognosis, said louis. Degennaro, phd, president and Chief Executive officer of The leukemia lymphoma society (LLS).

and educate healthcare professionals about the risks associated with Yescarta therapy. Training and certification on the rems program will be an integral part of the final authorization for centers offering Yescarta. Additional information about the rems program can be found. Please see below for Important Safety Information. Diffuse large b-cell lymphoma (dlbcl) is the most common aggressive non-Hodgkin lymphoma (nhl accounting for three out of every five cases. In the United States each year, there are approximately 7,500 patients with refractory dlbcl who are eligible for car t therapy. Historically, when treated with the current standard of care, patients with refractory large b-cell lymphoma had a median overall survival of approximately six months, with only seven percent attaining a complete response.

This press release features multimedia. View the full release here: m/news/home/ /en car t therapy is a breakthrough in study hematologic cancer treatment in which a patients own T cells are engineered to seek and destroy cancer cells. Car t therapy is manufactured specifically for each individual patient. The fda approval of Yescarta is a landmark for patients with relapsed or refractory large b-cell lymphoma. This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kites employees, said Arie belldegrun, md, facs, founder of Kite. We must also recognize the fda for their ability to embrace and support transformational new technologies that treat life-threatening illnesses. We believe this is only the beginning for car t therapies. Today is an important day for patients with relapsed or refractory large b-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer, said John Milligan, Phd, president and Chief Executive officer. With the combined innovation, talent and drive of the kite and Gilead teams, we will rapidly advance cell therapy research and aim to bring new options to patients with many other types of cancer.

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Worldwide sites, you have been detected as being from. Where applicable, you can see country-specific product information, offers, and pricing. Kites Yescarta (Axicabtagene ciloleucel) Becomes First CAherapy Approved by the fda for the Treatment of Adult Patients With Relapsed or Refractory large b-cell ions Lymphoma After Two or More lines of Systemic Therapy - manufacturing Success Rate of 99 Percent in zuma-1 pivotal Trial with. santa monica, calif.-(business wire)-Oct. 18, 2017- kite, a gilead Company, (Nasdaq: gild) today announced that the. Food and Drug Administration (FDA) has granted regular approval to yescarta (axicabtagene ciloleucel the first chimeric antigen receptor T cell (car t) therapy for the treatment of adult patients with relapsed or refractory large b-cell lymphoma after two or more lines of systemic therapy, including. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

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