Kite Pharma timeline from topline announcement to FDA approval (and buyout) as a reference for a possible best-case timeline for Northwest Bio (13 months topline to approval / 11 months topline to buyout):
Kite Pharma Announces Positive Topline KTE-C19 Data from ZUMA-1 Pivotal Trial in Patients with Aggressive Non-Hodgkin Lymphoma (NHL)
Study Met Primary Endpoint of Objective Response Rate
September 26, 2016 (Press Release) - SANTA MONICA, Calif.--Kite Pharma, Inc., (Nasdaq:KITE) today announced positive topline results from a pre-planned interim analysis of ZUMA-1 for its lead product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). KTE-C19 met the primary endpoint of objective response rate (ORR)
Kite Pharma Initiates Rolling Submission of BLA for KTE-C19, its Investigational anti-CD19 CAR-T Therapy, for the Treatment of Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL)
SANTA MONICA, Calif.--(BUSINESS WIRE) December 4, 2016 -- Kite Pharma, Inc. (Nasdaq:KITE) today announced that it has initiated the rolling submission with the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). The pivotal ZUMA-1 study supporting this submission enrolled patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL), three subtypes of aggressive NHL. The company expects to complete its BLA submission by the end of the first quarter of 2017.
"I am both proud and appreciative of the Kite team and our clinical investigators, who have helped to make this key milestone possible," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "This is an important first step toward Kite's biggest goal - bringing to market a potentially life-saving treatment for patients suffering from aggressive NHL."
Kite also announced that the United States Adopted Name, or USAN, for KTE-C19 will be axicabtagene ciloleucel.
Axicabtagene ciloleucel (KTE-C19) received Breakthrough Therapy Designation (BTD) by the FDA in December 2015. If approved, Kite plans to commercially launch KTE-C19 in 2017. Kite is also planning a regulatory submission to the European Medicines Agency (EMA) for axicabtagene ciloleucel in 2017. Kite was granted access to Priority Medicines (PRIME) regulatory support in 2016 by the EMA for axicabtagene ciloleucel (KTE-C19) for the treatment of refractory DLBCL.
Kite Completes Submission of U.S. Biologics License Application (BLA) for Axicabtagene Ciloleucel as the First CAR-T Therapy for the Treatment of Patients With Aggressive Non-Hodgkin Lymphoma (NHL)
SANTA MONICA, Calif. March 31, 2017 --(BUSINESS WIRE)-- Kite Pharma, Inc. (Nasdaq:KITE) today announced that it has completed the rolling submission with the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel (previously known as KTE-C19) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT)."Last month, we announced positive results from our ZUMA-1 pivotal trial with axicabtagene ciloleucel," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "We look forward to working closely with the FDA during the review of axicabtagene ciloleucel and the possibility of bringing this therapy to patients with aggressive NHL whose outlook is dismal with current therapy."
In December 2015 axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the FDA for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). If approved, Kite plans to commercially launch axicabtagene ciloleucel in 2017. Kite is also planning a regulatory submission to the European Medicines Agency (EMA) for axicabtagene ciloleucel in 2017.
"The Leukemia & Lymphoma Society (LLS) applauds Kite for achieving this significant milestone and bringing this promising therapy closer to patients with lymphoma who desperately need new options," said Louis J. DeGennaro, Ph.D., LLS President and Chief Executive Officer. "LLS has supported companies that are working to dramatically change cancer treatment through the development of immunotherapy for the past two decades, and we immediately recognized the great opportunity to support Kite's CAR-T program in 2015 through our Therapy Acceleration Program ® (TAP). Partnerships created through TAP, now in its tenth year, have the potential to bring several breakthrough therapies, such as axicabtagene ciloleucel, to patients in the coming year."
The ZUMA-1 pivotal trial for axicabtagene ciloleucel for the treatment of patients with aggressive NHL was supported in part by funding from LLS' TAP.
Kite Receives U.S. Food and Drug Administration Priority Review for Axicabtagene Ciloleucel
SANTA MONICA, Calif.--(BUSINESS WIRE) May 26, 2017 -- Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for axicabtagene ciloleucel. The submission follows positive data demonstrated with a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017.
"Patients with refractory aggressive NHL face a dire prognosis with only a 50 percent chance of surviving six months. This underscores the urgent medical need for these patients and why every day matters, from development to manufacturing to clinical experience," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "We firmly believe in the potential for axicabtagene ciloleucel to address this need and forge a new path for the future of cell therapy."
The filing acceptance is supported by data from the ZUMA-1 Phase 2 trial which met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel with 82 percent (p < 0.0001). At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR).
The most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). There were three deaths throughout the course of the registrational trial not due to disease progression, of which two events, were deemed related to axicabtagene ciloleucel.
In December 2015, axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for DLBCL, TFL, and PMBCL. The company expects to submit its Market Authorization Application (MAA) of axicabtagene ciloleucel with the European Medicines Agency (EMA) in the third quarter of 2017.
ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program®.
Gilead Sciences to Acquire Kite Pharma for $11.9 Billion
August 28, 2017 07:00 AM Eastern Daylight Time
FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc. (Nasdaq: KITE) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash. The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017. The transaction will provide opportunities for diversification of revenues, and is expected to be neutral to earnings by year three and accretive thereafter.
FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma
October 18, 2017 -- The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb, M.D. “This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to supporting and helping expedite the development of these products. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL in adults. NHLs are cancers that begin in certain cells of the immune system and can be either fast-growing (aggressive) or slow-growing. Approximately 72,000 new cases of NHL are diagnosed in the U.S. each year, and DLBCL represents approximately one in three newly diagnosed cases. Yescarta is approved for use in adult patients with large B-cell lymphoma after at least two other kinds of treatment failed, including DLBCL, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
Each dose of Yescarta is a customized treatment created using a patient’s own immune system to help fight the lymphoma. The patient’s T-cells, a type of white blood cell, are collected and genetically modified to include a new gene that targets and kills the lymphoma cells. Once the cells are modified, they are infused back into the patient.
“The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options – those adults with certain types of lymphoma that have not responded to previous treatments,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER).
