Arcellx’s cell therapy for multiple myeloma has shown no signs of the parkinsonism complication observed in clinical testing of Carvykti, a rival product from partners Johnson & Johnon and Legend Biotech. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.
Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.
Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare.
Autolus will apply the capital to its CAR T-cell therapy currently under FDA review in cancer and in early clinical development in lupus. Meanwhile, BioNTech will gain access to Autolus’s cell therapy manufacturing assets as well as technologies that could support the R&D of in vivo therapies and antibody drug conjugates.
Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.
CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.
Cargo Therapeutics will use most of the IPO proceeds for clinical testing of a cell therapy engineered to overcome a common way cancers develop resistance. This program is based on research from the National Cancer Institute.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
Johnson & Johnson is acquiring rights to two next-generation cell therapies from Cellular Biomedicines, both potential treatments for diffuse large B-cell lymphoma. One therapy is already in the clinic while the other is on track to begin human testing this year.
Cargo Therapeutics is developing CAR T-cell therapies that overcome ways cancers evade currently available treatments. True to its name, the startup’s approach involves putting more cargo and more complex cargo onto engineered T cells.
Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.
CAR-T has become increasingly recognized as an exciting and potentially paradigm-shifting treatment in the past five years. In fact, more than 10,000 patients have undergone this new treatment for certain types of leukemia, lymphoma and multiple myeloma.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
After settling in rural New Mexico, a cancer patient had to move 750 miles east and live in a trailer to access CAR-T treatment at the MD Anderson Cancer Center.
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.
As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.
CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple myeloma. The FDA approved Bristol Myers Squibb's cell therapy Abecma last year.