Eli Lilly (LLY) Lymphoma Candidate Pirtobrutinib Gets FDA Nod

Eli Lilly and Company LLY announced that the FDA, under an accelerated approval pathway, approved BTK inhibitor, pirtobrutinib (100 mg & 50 mg tablets) for the treatment of relapsed or refractory mantle cell lymphoma (MCL), in adult patients. The drug will be marketed by the trade name of Jaypirca and can be administered in patients who have had at least two lines of systemic therapy, including a BTK inhibitor.

The approval was based on Lilly’s global, open-label, phase I/II (BRUIN) study for multicenter evaluation of the administration of Jaypirca in adult patients with hematologic malignancies, including  MCL. The study comprised a phase I study to evaluate dose escalation, a phase Ib study to evaluate the combination component and a phase II study to expand the dosage in the patient population. The primary and secondary endpoints in each of the phases of the study were met with statistical significance in terms of safety and efficacy measured by an overall response rate of 50%, with complete response observed in 13% of the patient population. The continued approval of Jaypirca will be subject to verification and description of clear medical benefits in a confirmatory study by Lilly.

In the past year, shares of Lilly have risen 39.4% compared with the industry’s rise of 9.7%.

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Adverse reactions commonly observed in approximately 20% of the total patient population included decreased neutrophil count, decreased hemoglobin, decreased platelet count, fatigue, musculoskeletal pain, decreased lymphocyte count, bruising and diarrhea.

Management announced that Jaypirca will be available in the United States in the coming weeks and expressed the satisfaction of an unmet medical need in patients living with MCL who could no longer be treated with BTK inhibitors. The confirmatory phase III study (BRUIN MCL-321) is presently enrolling patients.

MCL is a rare form of B-cell non-Hodgkin lymphomas observed in about one out of 200000 people worldwide, annually. It is caused by the malignant transformation of a B lymphocyte.

However, Lilly’s Jaypirca is subject to stiff competition from AbbVie’s ABBV Imbruvica, which is approved for hematological cancers in five distinct disease areas. In the third quarter of 2023, AbbVie’s U.S. sales of Imbruvica grossed $849 million, down 23.5% from the year-ago figure. The U.S. sales of Imbruvica are being hurt by lower new patient starts in chronic lymphocytic leukemia due to delayed recovery from the pandemic and increasing competition from newer therapies. AbbVie’s share of profit from the international sales of Imbruvica rose 7.6% to $286 million. AbbVie market Imbruvica in partnership with J&J.

Zacks Rank and Stocks to Consider

Eli Lilly and Company currently holds a Zacks Rank #4 (Sell).

Some better-ranked large-cap pharmaceutical companies are Novo Nordisk NVO and Sanofi SNY, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, the Zacks Consensus Estimate for Novo Nordisk’s 2022 earnings per share has increased from $3.26 to $3.40. During the same period, the earnings estimate per share for 2023 has increased from $4.00 to $4.18.  In the past year, shares of Novo Nordisk have increased by 38.3%. Novo Nordisk delivered a four-quarter earnings surprise of 3.09% on average.

In the past 60 days, the estimate for Sanofi’s 2022 earnings per share has increased from $4.13 to $4.32. During the same period, the earnings estimate per share estimate  for 2023 has increased from $4.30 to $4.41. In the past year, the shares of Sanofi have decreased by 6.7%.

Sanofi’s earnings beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.50% on average.

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