gdc
FDA Approvals, News & UpdatesLymphomaFollicular Lymphoma

FDA Approved Ukoniq, New Targeted Therapy, for Marginal-Zone and Follicular Lymphoma

Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA, and is the first targeted, once-daily oral therapy option for marginal-zone or follicular lymphoma.
April 2021 Vol 7 No 2

In February 2021, the FDA approved Ukoniq (umbralisib; from TG Therapeutics), an oral kinase inhibitor, for the treatment of adults with relapsed or refractory marginal-zone lymphoma (MZL) or with relapsed or refractory follicular lymphoma. Ukoniq is used for MZL after 1 or more anti-CD20 therapies, and for follicular lymphoma after 3 or more lines of systemic therapy. Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA.

The FDA approval of Ukoniq was based on results from 2 cohorts that included 69 patients with MZL and 117 patients with follicular lymphoma who have previously received several lines of therapy. All patients received oral Ukoniq once daily until disease progression or until unacceptable side effects.

The overall response rate was 49% among the patients with MZL, with 16% reaching a complete response (remission). In the patients with follicular lymphoma, the overall response rate was 43%, including 3% complete responses.

The most common side effects with Ukoniq were diarrhea/colitis, fatigue, nausea, neutropenia, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.

Share this:

Recommended For You
FDA Approvals, News & UpdatesLymphoma
Brukinsa Approved for Marginal-Zone Lymphoma and for Waldenström’s Macroglobulinemia
In September 2021, the FDA approved Brukinsa oral capsules for adults with relapsed or refractory marginal-zone lymphoma. And in August, the FDA approved Brukinsa for adults with Waldenström’s macroglobulinemia, a rare, slow-growing type of non-Hodgkin lymphoma.
FDA Approvals, News & UpdatesCervical Cancer
Tivdak First Antibody–Drug Conjugate FDA Approved for Recurrent or Metastatic Cervical Cancer
In September, the FDA approved Tivdak (tisotumab vedotin) for the treatment of women with recurrent or metastatic cervical cancer that progressed during or after chemotherapy. This is the first tissue factor–directed antibody and microtubule inhibitor conjugate approved for women with advanced cervical cancer.
Last modified: April 28, 2021

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Country
Gender
Race or Ethnicity
Profession or Role
Primary Interest