FDA Approves Kite’s Yescarta for Relapsed/Refractory Large B-cell Lymphoma
The global biopharmaceutical company, Kite, a Gilead Company, has announced the FDA’s approval of their CAR-T cell therapy, Yescarta, for the treatment of adult patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). The first treatment improving current standard of care (SOC) for this indication in 30 years.
Warner Biddle, SVP, Worldwide Cell Therapy Commercial at Kite, a Gilead Company, describes, in the above video, what this approval means for patients of r/r LBCL and the future of CAR-T cell therapies as mainstream treatments.
Warner explains that, “We are effectively doubling the eligible patients who can get access now to Yescarta. It also means that these patients can get access to these therapies earlier, so they may have better outcomes.”
Focusing solely on developing cell therapies as treatments and potential cures for cancer, Kite’s Yescarta, under this new FDA approval, will be available to patients with LBCL if they have relapsed within 12 months of first-line chemotherapy, or are refractory to initial chemotherapy treatment.
The Phase III clinical trial ZUMA-7 demonstrated that 40.5% more patients who received a one-time Yescarta infusion were alive at the two-year follow-up, with no disease progression or additional treatment, compared to those receiving the current standard of care.
As a landmark trial, with the largest cohort and longest follow-up period to date of a trial of this type, it concluded that compared to the SOC Yescarta showed statistically significant and clinically meaningful improvements in event-free survival (EFS). The median EFS for patients receiving Yescarta was 8.3 months, four-times greater than the 2 months observed in the SOC.
Yescarta earlier this month received a Category 1 recommendation from the National Comprehensive Cancer Network for “Relapsed disease <12 mo or Primary Refractory disease” for LBCL, the first CAR-T cell therapy to do so.
Patients and Physicians will now be able to immediately access Yescarta LBCL under the specific r/r criteria across the U.S. in one of Kite’s 112 authorized treatment centers.
More than 18,000 people are diagnosed with LBCL in the U.S every year. 30-40% of these patients will experience a relapse or refractory response to first-line treatment. In order to support patient access to Yescarta Kite has invested in expanding their manufacturing capacity.
Christi Shaw, CEO of Kite comments, “Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy.”
Preceding this new indication success Yescarta received FDA approval for the treatment of LBCL patients who had failure in 2 or more lines of cancer therapy in 2017. This trial recently reported that 42.6% of the study patient population were alive 5 years post treatment, with 92% of these patients needing no additional treatment.
The ZUMA-7 safety profile for Yescarta was reported as consistent with previous studies. Of the 168 Yescarta-treated patients observed for safety 7% experienced cytokine release syndrome above a Grade 3, and 25% suffered neurological toxicities. Comparatively, high grade events were observed in 83% of patients receiving SOC.
“The growing portfolio that we have here at Kite is really establishing CAR-T therapy as not some science fiction treatment, but actually something that is really well established in the mainstream of medicine that can help a lot of patients,” concludes Warner Biddle.
Sources: Gilead Press Release