FDA Gives Accelerated Approval To Amgen's Drug For Small Cell Lung Cancer Patients
Portfolio Pulse from Vandana Singh
The FDA has granted accelerated approval to Amgen's drug Imdelltra for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after platinum-based chemotherapy. The approval is based on the response rate and duration of response observed in clinical studies. Continued approval may depend on further confirmatory trials. Imdelltra is the first DLL3-targeting Bispecific T-cell Engager therapy. Despite the positive news, AMGN shares traded lower by 0.94% at $311.75.
May 17, 2024 | 2:01 pm
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POSITIVE IMPACT
The FDA has granted accelerated approval to Amgen's Imdelltra for treating ES-SCLC, based on positive clinical trial results. Despite this, AMGN shares traded lower by 0.94%.
The FDA's accelerated approval of Imdelltra is a significant milestone for Amgen, potentially boosting its oncology portfolio. However, the stock traded lower, possibly due to market conditions or profit-taking. The long-term impact is likely positive as the drug addresses a critical need in cancer treatment.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100