Gilead’s CAR-T Therapy Yescarta Gets Approval in Europe
Gilead Sciences, Inc. GILD announced that the European Commission (EC) has granted Marketing Authorization to its chimeric antigen receptor T cell (CAR-T) therapy, Yescarta.
Yescarta is approved in Europe as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
CAR-T therapy harnesses a patient’s own immune system to fight certain types of blood cancer.
The Marketing Authorization Application (MAA) is supported by data from the ZUMA-1 trial in adult patients with refractory aggressive NHL.
We remind investors that Yescarta was approved by the FDA in October 2017.
Yescarta generated sales of $68 million in the second quarter of 2018, up from $40 million in the previous quarter.
Label expansion of existing drugs bode well for Gilead. The initial uptake of Yescarta also looks encouraging, but it will take some time for its sales to boost the top line significantly due to the high cost of treatment. Moreover, Novartis’ NVS Kymriah is also there in the market posing competition.
Recently, Kymriah won the EC approval for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) DLBCL, after two or more lines of systemic therapy, in Europe.
Gilead’s stock has gained 6.8% in the year so far compared to the industry’s decline of 3.5%.
Concurrent with the second-quarter earnings, Gilead announced that its CEO, John F. Milligan will step down after serving the company for 28 years. The departure of the CEO at this crucial time further clouds the growth prospects of the company. Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to help its top line.
During the first quarter, Gilead announced an agreement with Sangamo Therapeutics, Inc. SGMO to use Sangamo’s zinc finger nuclease technology platform for the development of next-generation ex vivo cell therapies in oncology. Gilead is also intending to foray into the NASH and inflammation market with late-stage candidates — selonsertib and filgotinib.
Gilead will have to generate substantial revenues from its HIV franchise and Yescarta to offset the HCV sales decline. This will be a challenging task for the company with stiff competition from the likes of GlaxoSmithKline GSK in the HIV market.
Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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