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Gilead (GILD) Tecartus Gets FDA Nod for Leukemia Indication
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Gilead’s (GILD - Free Report) wholly-owned subsidiary Kite announced that it has secured FDA approval for the chimeric antigen receptor (“CAR”) T-cell therapy, Tecartus, to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”) in patients aged 18 years and above. Following approval, Tecartus became the first and only CAR T-cell therapy approved for the given indication.
The FDA approval is based on positive data from the phase I/II ZUMA-3 study. The primary endpoint of this study was overall complete remission (“OCR”) i.e., complete remission (“CR”) and CR with incomplete hematological recovery (“Cri”). Data from the study demonstrated that 65% of patients treated with Tecartus achieved OCR at a median actual follow-up of 12.3 months.
The company’s regulatory filings for Tecartus in the EU and U.K. seeking approval for the above indication are currently under review.
Shares of Gilead have risen 17.7% so far this year against the industry’s 7.5% decline.
Image Source: Zacks Investment Research
Since treatment with Tecartus in clinical studies led to the occurrence of higher cytokine release syndrome and neurologic toxicities, the therapy is approved for the given indication under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. Per FDA, REMS is required for certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh its risks.
Please note that Tecartus is already approved by the FDA under accelerated approval for the treatment of relapsed or refractory mantle cell lymphoma in adult patients.
We inform investors that the approval of Tecartus in leukemia marks Kite’s fourth approval of CAR T-cell therapies. The company’s other CAR T-cell therapy, Yescarta, is approved to treat adult patients with relapsed or refractory large B-cell lymphoma (“LBCL”) after two or more lines of systemic therapy, including diffuse LBCL. Yescarta is also approved for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
We anticipate that the approval will provide a good impetus to the company’s CAR T-cell therapy franchise, which is slowly gaining traction. Last week, Kite filed a supplemental biologics license application with the FDA seeking label expansion for Yescarta for the treatment of LBCL in the second-line setting.
Though the company’s CAR T-cell therapy franchise is gaining traction, it is facing stiff competition from Novartis’ (NVS - Free Report) Kymriah, which is currently approved in the United States to treat patients up to 25 years of age with relapsed/refractory B-cell precursor ALL. Kymriah is also approved for the treatment of relapsed or refractory adult diffuse LBCL.
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the same sector include Moderna (MRNA - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy) at present, Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Moderna’s earnings per share estimates for 2021 have increased from $25.60 to $29.13 in the past 60 days. The same for 2022 has risen from $17.70 to $26.12 over the same period. The stock has rallied 226.5% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $61.41 in the past 60 days. The same for 2022 has risen from $40.91 to $46.73 over the same period. The stock has rallied 24.9% in the year so far.
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Gilead (GILD) Tecartus Gets FDA Nod for Leukemia Indication
Gilead’s (GILD - Free Report) wholly-owned subsidiary Kite announced that it has secured FDA approval for the chimeric antigen receptor (“CAR”) T-cell therapy, Tecartus, to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”) in patients aged 18 years and above. Following approval, Tecartus became the first and only CAR T-cell therapy approved for the given indication.
The FDA approval is based on positive data from the phase I/II ZUMA-3 study. The primary endpoint of this study was overall complete remission (“OCR”) i.e., complete remission (“CR”) and CR with incomplete hematological recovery (“Cri”). Data from the study demonstrated that 65% of patients treated with Tecartus achieved OCR at a median actual follow-up of 12.3 months.
The company’s regulatory filings for Tecartus in the EU and U.K. seeking approval for the above indication are currently under review.
Shares of Gilead have risen 17.7% so far this year against the industry’s 7.5% decline.
Since treatment with Tecartus in clinical studies led to the occurrence of higher cytokine release syndrome and neurologic toxicities, the therapy is approved for the given indication under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. Per FDA, REMS is required for certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh its risks.
Please note that Tecartus is already approved by the FDA under accelerated approval for the treatment of relapsed or refractory mantle cell lymphoma in adult patients.
We inform investors that the approval of Tecartus in leukemia marks Kite’s fourth approval of CAR T-cell therapies. The company’s other CAR T-cell therapy, Yescarta, is approved to treat adult patients with relapsed or refractory large B-cell lymphoma (“LBCL”) after two or more lines of systemic therapy, including diffuse LBCL. Yescarta is also approved for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
We anticipate that the approval will provide a good impetus to the company’s CAR T-cell therapy franchise, which is slowly gaining traction. Last week, Kite filed a supplemental biologics license application with the FDA seeking label expansion for Yescarta for the treatment of LBCL in the second-line setting.
Though the company’s CAR T-cell therapy franchise is gaining traction, it is facing stiff competition from Novartis’ (NVS - Free Report) Kymriah, which is currently approved in the United States to treat patients up to 25 years of age with relapsed/refractory B-cell precursor ALL. Kymriah is also approved for the treatment of relapsed or refractory adult diffuse LBCL.
Gilead Sciences, Inc. Price
Gilead Sciences, Inc. price | Gilead Sciences, Inc. Quote
Zacks Rank & Key Picks
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the same sector include Moderna (MRNA - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy) at present, Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Moderna’s earnings per share estimates for 2021 have increased from $25.60 to $29.13 in the past 60 days. The same for 2022 has risen from $17.70 to $26.12 over the same period. The stock has rallied 226.5% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $61.41 in the past 60 days. The same for 2022 has risen from $40.91 to $46.73 over the same period. The stock has rallied 24.9% in the year so far.