Yescarta’s recent developments
On August 27, Gilead Sciences’ (GILD) CAR-T[1.chimeric antigen receptor regulatory T-cell] therapy, Yescarta, secured approval from the European Commission as a treatment option for patients with primary mediastinal large B-cell lymphoma (or PMBCL) and relapsed or refractory diffuse large B-cell lymphoma (or DLBCL) who were previously treated with two or more therapies. Yescarta has been approved by the FDA for DLBCL, PMBCL, DLBCL due to follicular lymphoma, and high-grade B-cell lymphoma in patients who have undergone at least two systemic therapies.
In Q1 2018, Yescarta reported revenue of ~$68 million. Gilead Sciences has authorized ~60 US cancer centers to administer Yescarta. The company also plan to authorize 20 European cancer centers to administer Yescarta, with a focus on Germany and France, by the end of this year. Gilead Sciences is focusing on creating awareness among oncologists to refer patients to the cancer centers for cell therapy.
Yescarta’s manufacturing and access
Gilead Sciences has leased a 117,000-square-foot facility in the Netherlands to improve Yescarta’s distribution in Europe. Expected to be fully operational by 2020, the facility is aimed at reducing turnaround time by offering proximity to eligible patients in Europe. At the end of Q2 2018, most patients treated with Yescarta were either covered by commercial payers or were treated at prospective payment system-exempt cancer centers.
Yescarta’s research programs
Gilead Sciences is currently studying Yescarta as a second-line DLBCL indication in ZUMA-7, a Phase 3 trial. As the current standard of care is chemotherapy followed by autologous stem cell transplantation, the FDA’s approval of Yescarta could help patients avoid the complications associated with stem cell transplants.
Other cell therapy programs
In Q2 2018, Gilead Sciences entered into a collaboration with the National Cancer Institute to develop personalized cancer therapies targeting tumor neoantigens. In the next article, we’ll discuss Celgene’s gene therapy program.