TG Therapeutics & Onco360 Partner for Ukoniq Launch
UKONIQ™ (umbralisib) Now Approved by the FDA; Onco360® Selected as Exclusive Specialty Pharmacy Partner
February 08, 2021 11:00 AM Eastern Standard Time
Onco360® has been selected by TG Therapeutics, Inc. to be the exclusive specialty pharmacy partner for UKONIQTM (umbralisib), a new oral treatment for adult patients with relapsed refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed refractory follicular lymphoma who have received at least three prior lines of systemic therapy. These indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.
“The recent approval of UKONIQ unlocks a new therapy option for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). As a provider of this key treatment, Onco360 can support the highly specialized needs of MZL and FL patients and their physicians across the country.”
“Onco360 is excited to be selected as the exclusive specialty pharmacy provider for UKONIQ patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “The recent approval of UKONIQ unlocks a new therapy option for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). As a provider of this key treatment, Onco360 can support the highly specialized needs of MZL and FL patients and their physicians across the country.”
ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) mature B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a chronic and incurable disease. With an annual incidence of approximately 8,200 newly diagnosed patients in the United States, MZL is the third most common B-cell NHL, accounting for approximately ten percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL).
ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 13,200 newly diagnosed patients, FL is the most common indolent lymphoma accounting for approximately 17 percent of all NHL cases.
UKONIQ is marketed by TG Therapeutics, Inc., a commercial-stage biotechnology company focused on the acquisition, development, and commercialization of novel treatments. The FDA’s approval of UKONIQ was based on overall response rate data from the Phase 2 UNITY-NHL trial which evaluated the efficacy of UKONIQ in 69 patients with MZL who received at least 1 prior therapy (including an anti-CD20 regimen) and in 117 patients with FL who received at least 2 prior systemic therapies, including an anti-CD20 monoclonal antibody and an alkylating agent. For full prescribing information, visit www.tgtherapeutics.com.