Gilead’s Kite notched a new FDA approval for one of its CAR-T cell therapies.
The treatment, dubbed Tecartus, is now the first-ever CAR-T cell therapy approved for adults with relapsed or refractory mantle cell lymphoma (MCL). The agency granted Tecartus an accelerated approval late last week after data showed that 87 percent of patients responded to one dose of the treatment, and 62 percent showed a complete response.
MCL typically has a poor prognosis for patients and a median survival rate of just two to five years. The CEO of the Lymphoma Research Foundation called Tecartus a “new frontier in the treatment of this disease.”
Gilead plans to manufacture Tecartus at Kite’s facility in California. The complexity of manufacturing CAR-T cell therapies remains a challenge for drugmakers, who create the treatments by harvesting cells from patients, engineering those cells and then infusing them back into the patient. But Gilead, which acquired Kite in 2017, says that during the pivotal trial for Tecartus, Kite demonstrated a 96 percent manufacturing success rate and a median manufacturing turnaround time of 15 days from leukapheresis to product delivery.
Read the full press release.
