Search Results for “CART cell therapy ” – Page 2 – media

FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 102
- January 26, 2024
Gilead’s Tecartus gets revised safety demand amid FDA’s push for CAR-T boxed warnings

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, the agency has adjusted the wording of a proposed boxed warning. In a revised letter (PDF) dated Jan. 23, the FDA is still pressing Gilead’s cell therapy unit Kite Pharma to include new language about the risk of T-cell malignancies in the black-box warning section of Tecartus’ label. But unlike its proposed boxed warning for other commercial CAR-T therapies, the FDA’s updated letter for Tecartus no longer names Tecartus patients specifically as having experienced T-cell malignancies. The FDA apparently took some time before uploading the new letter after taking down the original one, dated Jan. 19. The missing letter for Tecartus caused a brief period of confusion because the FDA says in all letters to ...
- Source: drugdu
- 90
- January 26, 2024
FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The US Food and Drug Administration (FDA) has announced its intention to investigate the safety of CAR-T therapies following reports that they could be linked to the development of T-cell cancers. Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that involves collecting and using patients’ own immune cells to treat conditions including lymphoma, leukaemia and multiple myeloma. T-cell malignancies have been seen in patients treated with several approved products in the class, including Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). Currently, the potential risk of developing secondary malignancies is labelled as ...
- Source: drugdu
- 104
- December 4, 2023
Kite and Arcellx expand strategic collaboration

Gilead company Kite has expanded its existing partnership with Arcellx for the latter’s CART-ddBCMA candidate to include lymphomas. The parties entered an international strategic deal in December 2022 to jointly develop and market a CART-ddBCMA candidate for relapsed or refractory multiple myeloma. Kite has now exercised its licence option for ACLX-001, an ARC-SparX programme of Arcellx in multiple myeloma. Arcellx is entitled to receive an equity investment of $200m in exchange for 3,242,542 shares of its common stock. The funding will offer 13% ownership of Arcellx to Gilead. Arcellx is also eligible to receive $85m in upfront non-dilutive cash payment, separately from milestone payments in the future. The deal will close by the end of 2023. A BCMA-specific CAR-modified T-cell therapy of Arcellx, CART-ddBCMA is currently in a Phase II clinical trial. Kite executive vice-president Cindy Perettie stated: “We are pleased to see the momentum with the CART-ddBCMA multiple myeloma ...
- Source: drugdu
- 157
- November 20, 2023
New injectable cell therapy could resolve osteoarthritis

Wake Forest Institute for Regenerative Medicine (WFIRM) scientists have created a promising injectable cell therapy to treat osteoarthritis that both reduces inflammation and also regenerates articular cartilage. Recently identified by the Food and Drug Administration as a public health crisis, osteoarthritis affects more than 520 million people worldwide who deal with pain and inflammation. Osteoarthritis is typically induced by mechanical or traumatic stress in the joint, leading to damaged cartilage that cannot be repaired naturally. “Without better understanding of what drives the initiation and progression of osteoarthritis, effective treatment has been limited,” said lead author Johanna Bolander of WFIRM. “Initially, we studied what goes wrong in osteoarthritic joints, compared these processes to functional environments, and used this information to develop an immunotherapy cell treatment.” Osteoarthritis is a disease of the joint system. The joint includes a synovial membrane—a connective tissue that lines the inner surface of the joint. The membrane functions to protect the joint ...
- Source: drugdu
- 120
- April 25, 2023
J&J study data show dramatic benefit to multiple myeloma cell therapy

A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs. The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple myeloma, according to data from a study abstract that was briefly posted online Tuesday. The abstract showed Carvykti, which is made by Johnson & Johnson and Legend Biotech, reduced the risk of disease progression or death by 74% compared to standard of care — a degree of benefit that analysts who viewed it described as “stellar” and “highly encouraging.” J&J and Legend had previously said in late January that the study met its main goal, but did not disclose any specific data at the time. The abstract, which is no longer available online, was for presentation ...
- Source: drugdu
- 112
- April 20, 2023
Torque’s T cell ‘Backpacks’ Show Promising Results Against Solid Tumors

Gilead’s Yescarta and Novartis’ Kymriah garnered a lot of interest among T-cell therapies after producing high response rates in patients with lymphoma and leukemia. However, the same has not been true for this technology in cases of solid tumors. In this novel procedure, patients’ immune-boosting T cells are extracted and engineered to target and destroy cancer cells.
- Source: FierceBiotech
- 1,116
- July 11, 2018
cancer Researches T-cell therapies
FDA Approves CAR T Therapy for Large B-Cell Lymphoma Developed at University of Pennsylvania

Nation’s first approved personalized cellular therapy now available for second indication
- Source: pennmedicine.org
- 529
- May 8, 2018
B-cell lymphoma FDA Kymriah
CAR-T therapy could be available to NHS patients this year

NHS England chief executive Simon Stevens has indicated that chimeric antigen receptor T-cell therapy (CAR-T) could be available on the NHS this year, offering eligible patients a ‘ground-breaking’ approach to treating cancer.
- Source: pharmatimes
- 5,100
- April 28, 2018
cancer NHS T cell therapy
Autolus announces license agreement with UCL Business PLC for clinical-stage product candidate in development for the treatment of B-cell malignancies

- A CD19 CAR with novel targeting properties designed to reduce cytokine release syndrome –
- Source: autolus
- 586
- April 25, 2018
B-cell malignancies Market Views T-cell therapies

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