Big pharmaceutical companies that make personalized blood cancer treatments are working to cut the manufacturing turnaround time by as much as half in coming years, as they try to deliver them sooner in a patient’s disease course.
Tag Archive for: CAR-T therapy
Interius BioTherapeutics has received approval from Australia’s Human Research Ethics Committee to begin the first-in-human trial of an investigational in vivo CAR-T therapy designed to treat B-cell malignancies.
The companies leased interim results from the Phase III CARTITUDE-4 study, touting significant survival improvement in multiple myeloma patients after treatment with their CAR-T therapy Carvykti (ciltacabtagene autoleucel).
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
After winning approval earlier this month in follicular lymphoma, Bristol Myers Squibb’s Breyanzi got the FDA nod for another indication on Thursday: relapsed or refractory mantle cell lymphoma (MCL). Find out what other FDA approvals have recently gone through.
Following back-to-back approvals in lymphocytic leukemia, Bristol Myers Squibb’s CAR-T therapy Breyanzi on Wednesday won the FDA’s green light for relapsed or refractory follicular lymphoma.
In a joint conference event yesterday, cell therapy pioneer Carl June revealed unpublished results showing that in around 1,500 patients treated with CAR-T therapies, no cases of secondary malignancy could be definitively linked to the treatment.
The collaboration is designed to combine “the innovative cell therapy platforms from each of the companies,” according to the announcement.
Following a months-long safety review, the regulator said it is now requiring black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.