Expert OpinionPharma/Biotech Clinical

FDA Grants Traditional Approval To Eli Lilly And Co Pirtobrutinib For Chronic Lymphocytic Leukemia And Small Lymphocytic Lymphoma

BenzingaDecember 03, 2025 at 5:38 PMFull Content
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Detected Companies & Sentiment

Eli Lilly and Company
"strong positive momentum"
9

Gist

The FDA has granted traditional approval to Eli Lilly's pirtobrutinib for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, marking a significant milestone in cancer therapy.

LLM Summary

The U.S. FDA has granted traditional approval to Eli Lilly's pirtobrutinib for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), particularly those who have progressed on prior BTK inhibitors. This approval is based on clinical trial data demonstrating efficacy and safety. The decision supports pirtobrutinib as a key treatment option in a difficult-to-treat patient population.

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Metadata

Author:
Benzinga Newsdesk
Tickers:
LLY
Updated At:
December 03, 2025 at 1:38 PM
Benzinga Channels:
Biotech, News, General
Teaser:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic
Benzinga Stocks:
LLY (NYSE)
Benzinga Article ID:
49190877