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European Commission approves Amgen's IMDYLLTRA for small cell lung cancer

Created at 3 Jun · 2:39 PM7 sources↑ Market-relevant3 events
IN SHORT

The European Commission has approved Amgen's IMDYLLTRA (tarlatamab-dlle) for extensive-stage small cell lung cancer. Based on the Phase III DeLLphi-304 trial, IMDYLLTRA reduced the risk of death by 40% compared to chemotherapy, offering a new treatment option for patients with disease progression.

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Key Numbers

40%risk of death reduction

Who's Involved

European Commission
Regulatory body approving Amgen's drug
Amgen
Pharmaceutical company developing IMDYLLTRA

↳ Why This Matters

The approval provides a new treatment option for patients with extensive-stage small cell lung cancer, a condition with limited therapeutic choices, potentially improving survival outcomes.

Key facts

  • European Commission approved Amgen's IMDYLLTRA for extensive-stage small cell lung cancer.
  • Approval is based on Phase III DeLLphi-304 trial results.
  • IMDYLLTRA reduced the risk of death by 40% compared to chemotherapy.
  • It offers a new treatment option for patients with disease progression.

The European Commission has granted approval for Amgen's IMDYLLTRA (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This decision follows the positive results from the Phase III DeLLphi-304 clinical trial. The trial demonstrated that IMDYLLTRA significantly reduced the risk of death by 40% compared to the current standard of care, chemotherapy. This approval marks a significant advancement, providing a new therapeutic option for patients with SCLC who have experienced disease progression.

Frequently asked questions

IMDYLLTRA is approved for adult patients with extensive-stage small cell lung cancer (SCLC) who have experienced disease progression on or after platinum-based chemotherapy.

The Phase III DeLLphi-304 trial showed that IMDYLLTRA reduced the risk of death by 40% compared to chemotherapy.

Amgen is the pharmaceutical company that developed IMDYLLTRA.

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Cadence

How It Developed

3 Jun · 6:25 PM
EURÓPSKA KOMISIA SCHVÁLILA LIEK IMDYLLTRA® SPOLOČNOSTI AMGEN NA LIEČBU POKROČILÉHO ŠTÁDIA MALOBUNKOVÉHO KARCINÓMU PĽÚC
PRN | All News Releases via PiQSuite
3 Jun · 2:21 PM
The European Commission has approved Amgen's IMDYLLTRA® for extensive-stage small cell lung cancer, based on the DeLLphi-304 trial.
PRN | All News Releases via PiQSuite
3 Jun · 1:27 PM
LA CE APRUEBA IMDYLLTRA® DE AMGEN PARA EL CÁNCER DE PULMÓN DE CÉLULAS PEQUEÑAS EN ESTADIO AVANZADO
PRN | All News Releases via PiQSuite

Sources

T1
KOMISJA EUROPEJSA ZATWIERDZA PREPARAT IMDYLLTRA® FIRMY AMGEN DO LECZENIA DROBNOKOMÓRKOWEGO RAKA PŁUCA W POSTACI ROZSIANEJm.piqsuite.com
T1
EVROPSKÁ KOMISE SCHVÁLILA PŘÍPRAVEK IMDYLLTRA® OD SPOLEČNOSTI AMGEN K LÉČBĚ EXTENZIVNÍHO STADIA MALOBUNĚČNÉHO KARCINOMU PLICm.piqsuite.com
T1
EURÓPSKA KOMISIA SCHVÁLILA LIEK IMDYLLTRA® SPOLOČNOSTI AMGEN NA LIEČBU POKROČILÉHO ŠTÁDIA MALOBUNKOVÉHO KARCINÓMU PĽÚCm.piqsuite.com
T1
LA COMMISSION EUROPÉENNE APPROUVE IMDYLLTRA® D'AMGEN POUR LE TRAITEMENT DU CANCER DU POUMON À PETITES CELLULES DE STADE ÉTENDUm.piqsuite.com
T1
EUROPÄISCHE KOMMISSION ERTEILT ZULASSUNG FÜR IMDYLLTRA® VON AMGEN FÜR DIE BEHANDLUNG VON KLEINZELLIGEM LUNGENKREBS IM FORTGESCHRITTENEN STADIUMm.piqsuite.com
T1
ЕВРОПЕЙСКАЯ КОМИССИЯ ОДОБРИЛА ПРЕПАРАТ AMGEN IMDYLLTRA® ДЛЯ ЛЕЧЕНИЯ МЕЛКОКЛЕТОЧНОГО РАКА ЛЕГКОГО НА ЗАПУЩЕННОЙ СТАДИИm.piqsuite.com
T1
LA CE APRUEBA IMDYLLTRA® DE AMGEN PARA EL CÁNCER DE PULMÓN DE CÉLULAS PEQUEÑAS EN ESTADIO AVANZADOm.piqsuite.com

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