FDA Grants Second Conditional Approval For Eli Lilly's Rare Blood Cancer Drug
Portfolio Pulse from Vandana Singh
The FDA granted conditional approval for Eli Lilly's Jaypirca for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone at least two prior therapies. The approval, under the FDA's Accelerated Approval pathway, was based on the Phase 1/2 BRUIN trial results, which showed a 72% overall response rate. Jaypirca is the first FDA-approved non-covalent BTK inhibitor and comes with specific warnings and precautions. This follows a previous approval in January 2023 for a different indication.

December 04, 2023 | 12:06 pm
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Eli Lilly's Jaypirca received FDA conditional approval for treating CLL/SLL, showing strong trial results and marking its second indication approval. This could positively influence investor sentiment.
The FDA approval of Jaypirca for a new indication is a significant positive development for Eli Lilly, likely to increase investor confidence in the company's growth in the oncology market. The approval could lead to increased sales and revenue, positively impacting the stock price in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100