Gilead's (GILD) Tecartus Gets EC Nod for New Cancer Indication
Gilead Sciences, Inc.’s GILD wholly owned subsidiary, Kite, announced that the European Commission (EC) has approved its chimeric antigen receptor (CAR) T-cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL) in patients aged 26 and above.
Following the nod from EC, Tecartus became the first and only CAR T-cell therapy for treating the given indication in Europe.
The latest approval in Europe was based on data from the open-label, registrational phase I/II ZUMA-3 study, which evaluated Tecartus in adult patients with r/r ALL, an aggressive form of blood cancer. Data from the same showed that 71% of the evaluable patients achieved complete remission (“CR”) or CR with incomplete hematological recovery (CRi) with a median follow-up of 26.8 months.
The approval in Europe was expected as in July 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency rendered a positive opinion for Tecartus to treat r/r B-cell precursor ALL in patients aged 26 years and above.
Shares of Gilead have lost 12.7% this year compared with the industry’s decrease of 24.7%.
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Tecartus is currently approved in the United States and Europe for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL). Additionally, last year, Tecartus also secured FDA approval to treat relapsed or refractory B-cell precursor ALL in patients above 18 years of age.
In the first six months of 2022, Tecartus generated sales worth $136 million, reflecting an increase of 88.9% year over year. The label expansion of the drug into additional indications is likely to boost sales further in the days ahead.
The approval of Tecartus will also provide a good impetus to Gilead’s CAR T-cell therapy franchise, which is steadily gaining traction.
Zacks Rank & Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Achilles Therapeutics plc ACHL, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates have narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates have narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates have narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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