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Umbralisib

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December 18, 2023
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Treatment with acalabrutinib, umbralisib, ublituximab shows potential in CLL

Time-limited dual B-cell receptor inhibitor therapy with acalabrutinib, umbralisib and ublituximab showed potential in treatment-naive and relapsed/refractory chronic lymphocytic leukemia, according to data presented at ASH Annual Meeting.

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June 09, 2022
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Top in hem/onc: Impact of inflation on medical practices; FDA withdrawal of lymphoma drug

In the latest installment of Residency to Retirement, experts discussed how physicians can safeguard their assets from inflation. It was the top story in hematology/oncology last week.

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June 01, 2022
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Safety concerns prompt FDA to withdraw Ukoniq approval for two types of lymphoma

The FDA has withdrawn approval of umbralisib for marginal zone lymphoma and follicular lymphoma due to safety concerns, according to an updated drug safety communication.

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April 22, 2022
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FDA panel: PI3K inhibitor approvals for blood cancers should be backed by randomized data

The FDA Oncologic Drugs Advisory Committee voted Thursday in favor of randomized data to support future approvals of phosphatidylinositol-3-kinase inhibitors, which are being developed for patients with hematologic malignancies.

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February 03, 2022
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FDA investigates potential increased death risk with lymphoma therapy Ukoniq

The FDA is investigating a possible increased mortality risk with umbralisib, approved in the United States for treatment of two types of lymphoma.

News
December 14, 2021
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Umbralisib plus ublituximab benefits patients with CLL and Bruton TKI risk factors

The combination of umbralisib and ublituximab demonstrated superior PFS and overall response rates compared with chemoimmunotherapy among patients with chronic lymphocytic leukemia and Bruton tyrosine kinase inhibitor risk factors.

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February 05, 2021
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FDA approves Ukoniq for two lymphoma indications

The FDA granted accelerated approval to umbralisib for two types of relapsed or refractory lymphoma.

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December 17, 2020
4 min read
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Umbralisib-ublituximab combination extends PFS in CLL

The combination of umbralisib and ublituximab significantly improved PFS compared with chemoimmunotherapy for patients with chronic lymphocytic leukemia, according to study results presented at the virtual ASH Annual Meeting and Exposition.

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October 21, 2020
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FDA grants fast track designation to ublituximab plus umbralisib for CLL

The FDA granted fast track designation to the combination of ublituximab and umbralisib for the treatment of adults with chronic lymphocytic leukemia, according to a press release from the drugs’ manufacturer.

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August 13, 2020
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FDA grants priority review to umbralisib for marginal zone lymphoma

The FDA granted priority review to umbralisib for patients with previously treated marginal zone lymphoma, according to the agent’s manufacturer.

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