EMA Gives Positive Opinion to Lilly Treatment for Chronic Lymphocytic Leukemia

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Eli Lilly and Company (Lilly) announced on Feb. 28, 2025 that its Jaypirca (pirtobrutinib), a non-covalent or reversible Bruton's tyrosine kinase (BTK) inhibitor, was given a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), for treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) previously treated with a BTK inhibitor (1).

Jaypirca was one of 16 drugs for which CHMP extended therapeutic indications at its February meeting, EMA said on February 28 (2).

"We are pleased to receive a positive opinion from the CHMP, signaling that the European Union may lead the way in broadening patient access to Jaypirca for those with relapsed or refractory CLL in the post-BTK inhibitor setting," said Jacob Van Naarden, executive vice president and president of Lilly Oncology, in a Lilly press release (1). "There are currently no treatment options that have been specifically studied in a randomized Phase III trial in this patient population, and we are hopeful Jaypirca will be a meaningful new option for patients. We look forward to the European Commission [EC]'s decision in the coming months."

It could be one to two months for that decision from the EC, according to Lilly, following the release of data from—as Van Naarden alluded to—a Phase III trial (BRUIN CLL-321) that is the first randomized study in CLL ever to be conducted specifically among patients previously treated with a BTK inhibitor (1). Included in those results was a 46% reduction in the risk of disease progression or death after treatment with pirtobrutinib versus two global standards of care, either idelalisib or bendamustine plus rituximab.

Rituximab received a positive opinion from CHMP at its July 2024 meeting, for treatment of not only CLL but also rheumatoid arthritis, in the form of Ituxredi, a biosimilar referencing Roche’s MabThera (3).

In its press release, Lilly detailed CLL as a slow-growing form of non-Hodgkin lymphoma developed from lymphocytes, and for which cancer cells are present in the blood (1). There are approximately 100,000 new global cases of CLL each year, and it is one of the most common types of leukemia in adults.

"Results from the BRUIN CLL-321 trial show that Jaypirca delivers clinically meaningful outcomes in a post-BTK inhibitor setting with markedly prolonged time to next treatment, including in those with high-risk characteristics often associated with poor prognosis," Paolo Ghia, MD, professor of medical oncology at Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy, said in the Lilly press release (1). "Jaypirca allows for continued targeting of the BTK pathway following treatment with a covalent BTK inhibitor and has the potential to be an important new option in a setting with significant unmet need. The CHMP opinion is an important step toward bringing Jaypirca to patients in the European Union."

In the United States, Jaypirca was approved by FDA in 2023 under an accelerated approval pathway for treatment of adult patients with CLL or small lymphocytic lymphoma who have received at least two prior lines of therapy including a BTK inhibitor and BCL-2 inhibitor, or for treatment of adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy (1).

On February 26, Lilly announced the pending construction of four new US manufacturing sites, more than doubling its manufacturing investment in the country since 2020 to in excess of $50 billion total (4).

References

1. Eli Lilly and Company. Lilly's Jaypirca (pirtobrutinib) Recommended by CHMP for Approval in the European Union for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Previously Treated with a BTK Inhibitor. Press Release. Feb. 28, 2025.
2. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 February 2025. Press Release. Feb. 28, 2025.
3. EMA. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22–25 July 2024. Press Release. July 26, 2024.
4. Eli Lilly and Company. Lilly Plans to More Than Double US Manufacturing Investment Since 2020 Exceeding $50 Billion. Press Release. Feb. 26, 2025.