Eli Lilly and Company LLY announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending approval of its BTK inhibitor, Jaypirca (pirtobrutinib), for treating relapsed or refractory chronic lymphocytic leukemia (CLL) in patients who have been previously treated with a BTK inhibitor in the European Union. The approval was based on data from the phase III BRUIN CLL-321 study.

The European Commission is expected to give its decision in a couple of months. Jaypirca is already approved in the EU on a conditional basis for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a BTK inhibitor.

Lilly’s shares have risen 16.2% in the past year against a decline of 0.9% for the industry.

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LLY’s Jaypirca Sales Performance in 2024

Jaypirca was approved in the United States for treating CLL or small lymphocytic lymphoma in patients who have received at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor in December 2023. It was approved for the MCL indication in the United States in January 2023.

Jaypirca is one of Lilly’s several new drugs that have contributed to top-line growth in 2024. It recorded $337.0 million in sales in 2024. The drug is also being studied in earlier lines of therapy to enable broader use for the approved indications of CLL and MCL.

What BTK Inhibitors are Available Currently?

Some BTK inhibitors available in the market for CLL are AbbVie ABBV and J&J’s JNJ Imbruvica, AstraZeneca’s AZN Calquence or BeiGene’s Brukinsa.  In the last few quarters, sales of AbbVie/JNJ’s Imbruvica have been declining steadily amid rising competition from Brukinsa and AstraZeneca’s Calquence, all of which are approved by the FDA to treat similar indications. None of these drugs are approved for relapsed or refractory CLL in the post-BTK inhibitor setting.

LLY’s Zacks Rank

Eli Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Eli Lilly and Company Price and Consensus

Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote

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