Gilead Sciences’ Kite Pharma received FDA approval for a faster manufacturing process for its CAR-T cell therapy, according to an announcement on Tuesday. Kite said that its manufacturing of Yescarta (axicabtagene ciloleucel) will now bring its median turnaround time from 16 to 14 days.

Gilead Sciences company Kite published Phase II data for Yescarta (axicabtagene ciloleucel) for treating relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in Nature Medicine.

Yescarta is CD-19-directed autologous chimeric antigen receptor (CAR)-T cell therapy. It was first approved by the US Food and Drug Administration (FDA) for large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma.

First Treatment in Nearly 30 Years to Show Statistically Significant OS, With a Median Follow-Up of 47.2 Months, for Initial Treatment of R/R LBCL Versus Historical SOC in the Curative Setting --

-- Yescarta Results in a 27.4% Reduction in Risk of Death, Corresponding to a 38% Relative Improvement in OS, Despite 57% of Patients Subsequently Receiving Cell Therapy Off Protocol --

The results, the first for a CAR-T therapy, are further evidence supporting the use of the complex therapies earlier in a patient’s disease course.

There's been a yearslong will-they or won’t-they situation between England’s cost-effectiveness watchdog and Gilead’s Kite—as well as Novartis—for their respective CAR-T therapies. Now, Gilead has finally gotten the drug cost gatekeeper to warm up to its blood cancer cell therapy.

Daiichi Sankyo Co., Ltd. (DSKYF.PK) will transfer yescarta marketing authorization in Japan to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences Inc. (GILD), in 2023, the companies said in a statement.

After years of courtroom drama and amid a market clash, Bristol Myers Squibb has failed to open a new legal front in its cell therapy war with Gilead Sciences.

After leading the CAR-T field to a first-in-class FDA nod for earlier treatment of certain blood cancers, Gilead Sciences’ Yescarta looks on track to cross the finish line first in EU, too.

Kite, a Gilead company, says the US Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

Amid a flood of mostly bad news over its recent efforts in oncology, Gilead took a step back last week, presenting a long-term outlook at its prospects and showing how it plans to become a major cancer player by the end of the decade.