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VisitAmgen Receives Accelerated FDA Approval for New Lung Cancer Drug Imdelltra
May 16, 2024, 07:45 PM
Amgen has received accelerated approval from the U.S. Food and Drug Administration (FDA) on Thursday for its new drug, Imdelltra (tarlatamab), designed to treat adult patients with advanced small cell lung cancer (SCLC). This approval is specifically for patients whose disease has progressed despite chemotherapy. Imdelltra is a DLL3-targeting bispecific T-cell engager and represents a significant advancement in the treatment of this aggressive and most deadly form of lung cancer.
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Revenue from Imdelltra exceeds $1 billion • 25%
Revenue from Imdelltra is $500 million to $1 billion • 25%
Revenue from Imdelltra is $100 million to $500 million • 25%
Revenue from Imdelltra is less than $100 million • 25%
Significant increase • 25%
Moderate increase • 25%
No significant impact • 25%
Decrease due to other factors • 25%
Stock price increases by over 20% • 33%
Stock price increases by 10-20% • 33%
Stock price increases by less than 10% • 34%
Top performer • 33%
Average performer • 34%
Underperformer • 33%
Approved in EU • 25%
Approved in Asia • 25%
Approved in LATAM • 25%
Not approved in other regions • 25%
Restriction on use broadened • 33%
No further action • 33%
Additional warnings issued • 33%
Multiple regions including EU, UK, and Japan • 25%
UK only • 25%
EU only • 25%
Japan only • 25%