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Gilead (GILD) Files sBLA to FDA for Yescarta Label Expansion
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Gilead Sciences, Inc. (GILD - Free Report) announced that its wholly owned subsidiary, Kite, has submitted a supplemental biologics license application (sBLA) to the FDA for the label expansion of its chimeric antigen receptor (“CAR”) T-cell therapy, Yescarta (axicabtagene ciloleucel). The company is seeking approval of Yescarta for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (“LBCL”) in the second-line setting.
If approved for the new indication, Yescarta will become the first CAR T-Cell therapy for treating LBCL in adult patients who relapse after or are refractory to first-line therapy.
The above sBLA was based on data from the global phase III ZUMA-7 study. In June 2021, the company announced positive top-line results from the same.
Results showed the superiority of Yescarta over the standard of care (“SOC”) in the given patient population. Yescarta improved event-free survival by 60% versus SOC in second-line relapsed or refractory LBCL – the primary endpoint. The study also met the key secondary endpoint of objective response rate.
Shares of Gilead have rallied 19.9% so far this year against the industry’s decline of 5.7%.
Image Source: Zacks Investment Research
We note that, Yescarta is currently indicated for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma. The drug is also approved for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Gilead acquired Kite Pharma to foray into the emerging field of cell therapy. Kite is a pioneer in cell therapy, having developed engineered cell therapies that express either a CAR or an engineered T cell receptor, depending on the type of cancer.
Gilead’s CAR T cell therapy franchise comprises of Yescarta and Tecartus. Tecartus is approved for the treatment of relapsed or refractory mantle cell lymphoma. Both drugs are gaining traction and have bolstered the cell therapy product franchise for the company.
The massive decline in sales of Gilead’s HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues. The approval of other indications for these therapies will boost the franchise’s performance. However, competition remains stiff from the likes of Novartis’ (NVS - Free Report) Kymriah. The FDA recently approved Bristol-Myers’ (BMY - Free Report) Breyanzi, a CAR T cell therapy for certain types of non-Hodgkin lymphoma. Allogene Therapeutics, Inc (ALLO - Free Report) is another player in this evolving innovative field of CAR T cell therapies.
Image: Bigstock
Gilead (GILD) Files sBLA to FDA for Yescarta Label Expansion
Gilead Sciences, Inc. (GILD - Free Report) announced that its wholly owned subsidiary, Kite, has submitted a supplemental biologics license application (sBLA) to the FDA for the label expansion of its chimeric antigen receptor (“CAR”) T-cell therapy, Yescarta (axicabtagene ciloleucel). The company is seeking approval of Yescarta for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (“LBCL”) in the second-line setting.
If approved for the new indication, Yescarta will become the first CAR T-Cell therapy for treating LBCL in adult patients who relapse after or are refractory to first-line therapy.
The above sBLA was based on data from the global phase III ZUMA-7 study. In June 2021, the company announced positive top-line results from the same.
Results showed the superiority of Yescarta over the standard of care (“SOC”) in the given patient population. Yescarta improved event-free survival by 60% versus SOC in second-line relapsed or refractory LBCL – the primary endpoint. The study also met the key secondary endpoint of objective response rate.
Shares of Gilead have rallied 19.9% so far this year against the industry’s decline of 5.7%.
We note that, Yescarta is currently indicated for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma. The drug is also approved for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Gilead acquired Kite Pharma to foray into the emerging field of cell therapy. Kite is a pioneer in cell therapy, having developed engineered cell therapies that express either a CAR or an engineered T cell receptor, depending on the type of cancer.
Gilead’s CAR T cell therapy franchise comprises of Yescarta and Tecartus. Tecartus is approved for the treatment of relapsed or refractory mantle cell lymphoma. Both drugs are gaining traction and have bolstered the cell therapy product franchise for the company.
The massive decline in sales of Gilead’s HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues. The approval of other indications for these therapies will boost the franchise’s performance. However, competition remains stiff from the likes of Novartis’ (NVS - Free Report) Kymriah. The FDA recently approved Bristol-Myers’ (BMY - Free Report) Breyanzi, a CAR T cell therapy for certain types of non-Hodgkin lymphoma. Allogene Therapeutics, Inc (ALLO - Free Report) is another player in this evolving innovative field of CAR T cell therapies.
Zacks Rank
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.