PharmaMar Recibe el Ok de la FDA Para Iniciar Fase I con PM54 en Combi con Inmuno Para Posible Tratamiento . PARA EI RELEVO DE LURBINECTEDIN ESTABAN PM184 Y PM14 AMBOS RETIRADOS POR LA CIA. AHORA HAY OTROS DOS FÁRMACOS EN FASE I EN EL INTENTO DE RELEVAR A LURBINECTEDIN : PM54 Y PM534 ... EL PROBLEMA ES QUE AMBOS AÚN ESTAN EN FASE I CON TODO LO QUE ESTO IMPLICA EN CUESTIÓN DE PLAZOS ... YA QUE PARA REALUZAR 3 FASES CLÍNICAS HACEN FALTA DE 12 A 15 AÑOS ... NOS IRÍAMOS AL 2040.
24 septiembre 2025
IMFORTE . LURBINECTEDIN ( BY PHARMAMAR / JAZZPHARMA ) / ATEZOLIZUMAB ( BY ROCHE / GENENTECH ) ... CITA TOPE CON LA US FDA EL PRÓXIMO 7 DE OCTUBRE 2025 .
Jazz Pharmaceuticals plc (JAZZ) .
Jazz Pharma's Zepzelca, in combination with Roche's Tecentriq as a first-line maintenance treatment for people with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with Tecentriq, carboplatin, and etoposide, is under Priority Review by the FDA, with a decision due on October 7, 2025.
In a phase III trial, Zepzelca plus Tecentriq demonstrated statistically significant and clinically meaningful improvements in both progression-free and overall survival in the extensive-stage small cell lung cancer first-line maintenance setting.
Zepzelca received the FDA's accelerated approval in June 2020 for the treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
The drug generated annual net product sales of $320.3 million in 2024, up 11% over the prior year.
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