US FDA Approves Amgen Drug For Small Cell Lung Cancer . 8 Ensayos Clínicos en Marcha Tiene Actualmente AMGEN Con TARLATAMAB SCLC Tanto Para 1.ª Línea Como Para el Mantenimiento de 1.ª Línea y También Para SEGUNDA LÍNEA ( Vs Lurbinectedin ) . TIENE STSUS DE OD Y FAST TRACK .

SMALL CELL LUNG CÁNCER . L@S ONCÓLOG@S EN EEUU YA DISPONEN DE UN NUEVO TRATAMIENTO . LA FDA HA APROBADO IMDELLTRA ( TARLATAMAB BY AMGEN ) PARA PODER TRATAR A LOS PACIENTES CON PROGRESIÓN DE LA ENFERMEDAD DURANTE O DESPUÉS DE UNA QUIMIOTERAPIA BASADA EN PLATINO .

La FDA Ha Concedido una Aprobación Condicional Acelerada a TARLATAMAB Para el Tratamiento de Pacientes  Con Cancer de Pulmón de Células Pequeñas en Estadio Extenso .

 La Aprobación se Basa en Resultados de FASE II . 

Su Posible Aprobación Estaba Prevista Que Pudiera Producirse el 12 de Junio Tras el Congreso ASCO ... Pero es Tanta la Necesidad de Poder Tener a Mano un Tratamiento Efectivo ... Qué la FDA le Ha Concedido Ya la Aprobación Condicional Acelerada .

Ahora Dependerá de los Oncólog@s US su Administración .

FDA GRANTS ACCELERATED APPROVAL TO TARLATAMAB - DLLE FOR EXTENSIVE STAGE SMALL CELL LUNG CÁNCER .

On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy .

Efficacy And Safety

Efficacy was evaluated in 99 patients with relapsed/refractory ES-SCLC with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study. Patients with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded. Patients received tarlatamab until disease progression or unacceptable toxicity.

The major efficacy outcome measures were overall response rate (ORR) per RECIST 1.1 and duration of response (DOR), as assessed by blinded independent central review. ORR was 40% (95% CI: 31, 51) and median DOR was 9.7 months (range 2.7, 20.7+). Of the 69 patients with available data regarding platinum sensitivity status, the ORR was 52% (95% CI 32, 71) in 27 patients with platinum-resistant SCLC (defined as progression < 90 days after last dose of platinum therapy) and 31% (95% CI 18, 47) in 42 patients with platinum-sensitive SCLC (defined as progression ≥ 90 days after last dose of platinum therapy).

The prescribing information for tarlatamab-dlle includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). The most common adverse reactions (>20%) were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea. The most common Grade 3 or 4 laboratory abnormalities (≥5%) were decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium.

The recommended tarlatamab dose is an initial dose of 1 mg administered as an intravenous infusion over 1 hour on Cycle 1 Day 1, followed by 10 mg on Cycle 1 Day 8 and Day 15 then every 2 weeks thereafter until disease progression or unacceptable toxicity .

Expedited Programs

This REVIEW used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 1 month ahead of the FDA goal date .

This application was granted accelerated approval based on overall response rate and duration of response. Continued approval may be contingent upon verification of clinical benefit .

This application was granted priority review, breakthrough designation, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics .