FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma

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The FDA based its approval on evidence from the single-arm, LY-004 clinical study, for which researchers enrolled 124 patients with MCL to receive acalabrutinib 100 mg twice daily.
The FDA based its approval on evidence from the single-arm, LY-004 clinical study, for which researchers enrolled 124 patients with MCL to receive acalabrutinib 100 mg twice daily.

The US Food and Drug Administration (FDA) has granted accelerated approval to acalabrutinib, a Bruton's kinase inhibitor, for adult patients with mantle cell lymphoma (MCL) previously treated with at least 1 line of therapy.1

MCL is an aggressive, rare form of non-Hodgkin lymphoma (NHL) that accounts for approximately 5% of all NHLs. At detection, MCL has typically spread to other organs, bone marrow, and the lymph nodes.

The FDA based its approval on evidence from the single-arm LY-004 clinical study (ClinicalTrials.gov Identifier: NCT02213926), for which researchers enrolled 124 patients with MCL to receive acalabrutinib 100 mg twice daily. The median time from diagnosis was 46.3 months; patients had received a median of 2 previous treatments; 18% of patients had received prior stem cell transplant.

After a median follow-up of 15.2 months, the overall response rate was 81% (95% CI, 73%-87%), with 40% (95% CI, 31%-49%) and 41% (95% CI, 32%-50%) of patients reaching a complete or partial response, respectively. The median time to best response was 1.9 months.

The most frequently reported adverse events included anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising. Serious side effects reported for acalabrutinib include hemorrhage, atrial fibrillation, and infections; there have also been reports of second primary malignancies.

The FDA granted Priority Review, Breakthrough Therapy, and Orphan Drug designations to acalabrutinib.

References

  1. FDA approves new treatment for adults with mantle cell lymphoma [news release]. Silver Spring, MD: US Food and Drug Administration; October 31, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583076.htm. Accessed October 31, 2017.

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