Kite Says Tecartus Shows Prolonged OS In Adults With Refractory B-cell Acute Lymphoblastic Leukemia

RTTNews | 169 dias atrás
Kite Says Tecartus Shows Prolonged OS In Adults With Refractory B-cell Acute Lymphoblastic Leukemia

(RTTNews) - Kite, a Gilead Sciences, Inc. Company (GILD), announced Monday updated, four-year overall survival (OS) data from the pivotal ZUMA-3 study evaluating the CAR T-cell therapy Tecartus (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

The findings showed a median Overall Survival (OS) of 25.6 months and a four-year OS rate of 40% in all treated patients with a safety profile consistent with that observed in the three-year analysis.

ZUMA-3 is an ongoing international multicenter (US, Canada, Europe), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation.

The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment.

The duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and alloSCT rate were assessed as secondary endpoints.

Marcadores : GILD
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Gilead Recalls COVID-19 Drug Veklury For Injection

Gilead Recalls COVID-19 Drug Veklury For Injection

Foster City, California-based Gilead Sciences, Inc. is recalling one lot of Veklury (remdesivir) for Injection 100 mg/vial for treating COVID-19, to the consumer level, due to the presence of a glass particle, according to the U.S. Food and Drug Administration. The recall involves Veklury (remdesivir 100mg for injection) with NDC 61958-2901-02, lot # 47035CFA and Expiration Date 11/2025.
RTTNews | 56 dias atrás
Gilead Sciences Says FDA OK's Updated Label Of Biktarvy To Treat Pregnant People With HIV-1

Gilead Sciences Says FDA OK's Updated Label Of Biktarvy To Treat Pregnant People With HIV-1

Gilead Sciences, Inc. (GILD) announced Friday the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads.
RTTNews | 207 dias atrás
Gilead Sciences Says CHMP Adopts Positive Opinion To Extend Indication Of Veklury

Gilead Sciences Says CHMP Adopts Positive Opinion To Extend Indication Of Veklury

Gilead Sciences, Inc. (GILD) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 as well as pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).
RTTNews | 795 dias atrás