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UKONIQ is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) 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.

IMPORTANT SAFETY INFORMATION
  • Infections: Serious, including fatal, infections occurred in patients treated with UKONIQ. Grade 3 or higher infections occurred in 10% of 335 patients, with fatal infections occurring in <1%. The most frequent Grade ≥3 infections included pneumonia, sepsis, and urinary tract infection. Provide prophylaxis for Pneumocystis jirovecii pneumonia (PJP) and consider prophylactic antivirals during treatment with UKONIQ to prevent CMV infection, including CMV reactivation. Monitor for any new or worsening signs and symptoms of infection, including suspected PJP or CMV, during treatment with UKONIQ. For Grade 3 or 4 infection, withhold UKONIQ until infection has resolved. Resume UKONIQ at the same or a reduced dose. Withhold UKONIQ in patients with suspected PJP of any grade and permanently discontinue in patients with confirmed PJP. For clinical CMV infection or viremia, withhold UKONIQ until infection or viremia resolves. If UKONIQ is resumed, administer the same or reduced dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly.
  • Neutropenia: Serious neutropenia occurred in patients treated with UKONIQ. Grade 3 neutropenia developed in 9% of 335 patients and Grade 4 neutropenia developed in 9%. Monitor neutrophil counts at least every 2 weeks for the first 2 months of UKONIQ and at least weekly in patients with neutrophil count <1 x 109/L (Grade 3-4) neutropenia during treatment with UKONIQ. Consider supportive care as appropriate. Withhold, reduce dose, or discontinue UKONIQ depending on the severity and persistence of neutropenia.
  • Diarrhea or Non-Infectious Colitis: Serious diarrhea or non-infectious colitis occurred in patients treated with UKONIQ. Any grade diarrhea or colitis occurred in 53% of 335 patients and Grade 3 occurred in 9%. For patients with severe diarrhea (Grade 3, i.e., >6 stools per day over baseline) or abdominal pain, stool with mucus or blood, change in bowel habits, or peritoneal signs, withhold UKONIQ until resolved and provide supportive care with antidiarrheals or enteric acting steroids as appropriate. Upon resolution, resume UKONIQ at a reduced dose. For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue UKONIQ. Discontinue UKONIQ for life-threatening diarrhea or colitis.
  • Hepatotoxicity: Serious hepatotoxicity occurred in patients treated with UKONIQ. Grade 3 and 4 transaminase elevations (ALT and/or AST) occurred in 8% and <1%, respectively, in 335 patients. Monitor hepatic function at baseline and during treatment with UKONIQ. For ALT/AST greater than 5 to less than 20 times ULN, withhold UKONIQ until return to less than 3 times ULN, then resume at a reduced dose. For ALT/AST elevation greater than 20 times ULN, discontinue UKONIQ.
  • Severe Cutaneous Reactions: Severe cutaneous reactions, including a fatal case of exfoliative dermatitis, occurred in patients treated with UKONIQ. Grade 3 cutaneous reactions occurred in 2% of 335 patients and included exfoliative dermatitis, erythema, and rash (primarily maculo-papular). Monitor patients for new or worsening cutaneous reactions. Review all concomitant medications and discontinue any potentially contributing medications. Withhold UKONIQ for severe (Grade 3) cutaneous reactions until resolution. Monitor at least weekly until resolved. Upon resolution, resume UKONIQ at a reduced dose. Discontinue UKONIQ if severe cutaneous reaction does not improve, worsens, or recurs. Discontinue UKONIQ for life-threatening cutaneous reactions or SJS, TEN, or DRESS of any grade. Provide supportive care as appropriate.
  • Allergic Reactions Due to Inactive Ingredient FD&C Yellow No. 5: UKONIQ contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons, frequently in patients who also have aspirin hypersensitivity.
  • Embryo-fetal Toxicity: Based on findings in animals and its mechanism of action, UKONIQ can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.
  • Serious adverse reactions occurred in 18% of 221 patients who received UKONIQ. Serious adverse reactions that occurred in ≥2% of patients were diarrhea-colitis (4%), pneumonia (3%), sepsis (2%), and urinary tract infection (2%). Permanent discontinuation of UKONIQ due to an adverse reaction occurred in 14% of patients. Dose reductions of UKONIQ due to an adverse reaction occurred in 11% of patients. Dosage interruptions of UKONIQ due to an adverse reaction occurred in 43% of patients.
  • The most common adverse reactions (>15%), including laboratory abnormalities, in 221 patients who received UKONIQ were increased creatinine (79%), diarrhea-colitis (58%, 2%), fatigue (41%), nausea (38%), neutropenia (33%), ALT increase (33%), AST increase (32%), musculoskeletal pain (27%), anemia (27%), thrombocytopenia (26%), upper respiratory tract infection (21%), vomiting (21%), abdominal pain (19%), decreased appetite (19%), and rash (18%).
  • Lactation: Because of the potential for serious adverse reactions from umbralisib in the breastfed child, advise women not to breastfeed during treatment with UKONIQ and for at least one month after the last dose.

References: 1. UKONIQ [prescribing information]. New York, NY: TG Therapeutics; 2021. 2. TG Therapeutics, Inc. data on file.

INDICATIONS

UKONIQ is indicated for the treatment of adult patients with:

  • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least 1 prior anti-CD20-based regimen
  • Relapsed or refractory follicular lymphoma (FL) who have received at least 3 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.

Please see full Prescribing Information.

DISEASE CONTROL RATE WAS 80% IN PATIENTS WITH R/R FL1,2

49% of patients with R/R MZL responded to UKONIQ

ORR* 43
(n=50; 95% CI, 33.6-52.2)

Percentage

  • 70
  • 60
  • 50
  • 40
  • 30
  • 20
  • 10
  • 0

Achieved ORR

CR 3.4 (n=4)

PR 39 (n=46)

49% of patients with R/R MZL responded to UKONIQ

Disease Control Rate
(CR+PR+SD)=80%

Percentage

  • 70
  • 60
  • 50
  • 40
  • 30
  • 20
  • 10
  • 0

Achieved SD

SD 37 (n=43)

MEDIAN FOLLOW-UP OF 20.1 MONTHS (RANGE, 13.5-29.6)

DISEASE CONTROL RATE: the number of patients who achieved CR, PR, and SD.

UKONIQ was evaluated in a single-arm cohort of 117 patients with FL who received at least 2 prior systemic therapies in UNITY-NHL, an open-label, multicenter, multi-cohort trial. The trial excluded patients with Grade 3b FL, large-cell transformation, prior allogeneic transplant, history of CNS lymphoma, and prior exposure to a PI3K inhibitor. Efficacy was based on ORR as assessed by an IRC using criteria adopted from the IWG for malignant lymphoma.

Limitations: The study was not powered to determine efficacy based on disease control rate. It is not possible to determine if stable disease is experienced as a result of the natural progression of disease or treatment with UKONIQ.

CI=confidence interval; CR=complete response; IRC=independent review committee; IWG=International Working Group; ORR=overall response rate; PR=partial response; R/R=relapsed or refractory; SD=stable disease.
mDOR 11.1 months (95% CI, 8.3-16.4; range, 0.0-20.9) with a median follow-up of 20.1 months (range, 13.5-29.6)1‡

DOR rate among patients who achieved PR/CR (n=50)

DOR=duration of response; mDOR=median duration of response.

Learn more about FL EFFICACY DATA

NEARLY 50%
OF RESPONDERS
WITH R/R FL WERE
STILL RESPONDING
AT 1 YEAR2

Percent change of target lesions

THRESHOLD
FOR OBJECTIVE
RESPONSE MET BY
43% OF PATIENTS
Maximum percent change (from baseline SPD) of target lesions was determined by IRC assessment in 111 of 117 patients with FL2

Limitations:

The clinical meaningfulness of a change in target lesions not meeting the threshold for an objective response (SPD <50% from baseline) is unclear
The change in target lesion size may not reflect confirmed responses and may not account for new lesions
  • *Responses were assessed by IRC using criteria adopted from the International Working Group (IWG) criteria for malignant lymphoma.
  • Denotes censored observation.
  • Based on Kaplan-Meier estimation. DOR rates were determined from non-parametric estimation of the Kaplan-Meier analysis at 6 and 12 months, respectively.
  • §Percent change in target lesions was determined by 2007 IWG criteria. Patients with a change in target lesions not meeting the threshold for an objective response (SPD <50% from baseline) were classified as having stable disease or progressive disease depending on the percent change in target lesions and other factors including the presence of new lesions.

SPD=sum of the products of the longest perpendicular diameters.

CHANGE IN TUMOR BURDEN FROM BASELINE

Maximum percent change (from baseline SPD) of target lesions was determined by IRC assessment in 111 of 117 patients with FL2

Limitations:

The clinical meaningfulness of a change in target lesions not meeting the threshold for an objective response (SPD <50% from baseline) is unclear
The change in target lesion size may not reflect confirmed responses and may not account for new lesions
  • *Responses were assessed by IRC using criteria adopted from the International Working Group (IWG) criteria for malignant lymphoma.
  • Denotes censored observation.
  • Based on Kaplan-Meier estimation. DOR rates were determined from non-parametric estimation of the Kaplan-Meier analysis at 6 and 12 months, respectively.
  • §Percent change in target lesions was determined by 2007 IWG criteria. Patients with a change in target lesions not meeting the threshold for an objective response (SPD <50% from baseline) were classified as having stable disease or progressive disease depending on the percent change in target lesions and other factors including the presence of new lesions.

SPD=sum of the products of the longest perpendicular diameters.

indications

UKONIQ is indicated for the treatment of adult patients with:

  • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least 1 prior anti-CD20-based regimen
  • Relapsed or refractory follicular lymphoma (FL) who have received at least 3 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.

important safety information

  • Infections: Serious, including fatal, infections occurred in patients treated with UKONIQ. Grade 3 or higher infections occurred in 10% of 335 patients, with fatal infections occurring in <1%. The most frequent Grade ≥3 infections included pneumonia, sepsis, and urinary tract infection. Provide prophylaxis for Pneumocystis jirovecii pneumonia (PJP) and consider prophylactic antivirals during treatment with UKONIQ to prevent CMV infection, including CMV reactivation. Monitor for any new or worsening signs and symptoms of infection, including suspected PJP or CMV, during treatment with UKONIQ. For Grade 3 or 4 infection, withhold UKONIQ until infection has resolved. Resume UKONIQ at the same or a reduced dose. Withhold UKONIQ in patients with suspected PJP of any grade and permanently discontinue in patients with confirmed PJP. For clinical CMV infection or viremia, withhold UKONIQ until infection or viremia resolves. If UKONIQ is resumed, administer the same or reduced dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly.
  • Neutropenia: Serious neutropenia occurred in patients treated with UKONIQ. Grade 3 neutropenia developed in 9% of 335 patients and Grade 4 neutropenia developed in 9%. Monitor neutrophil counts at least every 2 weeks for the first 2 months of UKONIQ and at least weekly in patients with neutrophil count <1 x 109/L (Grade 3-4) neutropenia during treatment with UKONIQ. Consider supportive care as appropriate. Withhold, reduce dose, or discontinue UKONIQ depending on the severity and persistence of neutropenia.
  • Diarrhea or Non-Infectious Colitis: Serious diarrhea or non-infectious colitis occurred in patients treated with UKONIQ. Any grade diarrhea or colitis occurred in 53% of 335 patients and Grade 3 occurred in 9%. For patients with severe diarrhea (Grade 3, i.e., >6 stools per day over baseline) or abdominal pain, stool with mucus or blood, change in bowel habits, or peritoneal signs, withhold UKONIQ until resolved and provide supportive care with antidiarrheals or enteric acting steroids as appropriate. Upon resolution, resume UKONIQ at a reduced dose. For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue UKONIQ. Discontinue UKONIQ for life-threatening diarrhea or colitis.
  • Hepatotoxicity: Serious hepatotoxicity occurred in patients treated with UKONIQ. Grade 3 and 4 transaminase elevations (ALT and/or AST) occurred in 8% and <1%, respectively, in 335 patients. Monitor hepatic function at baseline and during treatment with UKONIQ. For ALT/AST greater than 5 to less than 20 times ULN, withhold UKONIQ until return to less than 3 times ULN, then resume at a reduced dose. For ALT/AST elevation greater than 20 times ULN, discontinue UKONIQ.
  • Severe Cutaneous Reactions: Severe cutaneous reactions, including a fatal case of exfoliative dermatitis, occurred in patients treated with UKONIQ. Grade 3 cutaneous reactions occurred in 2% of 335 patients and included exfoliative dermatitis, erythema, and rash (primarily maculo-papular). Monitor patients for new or worsening cutaneous reactions. Review all concomitant medications and discontinue any potentially contributing medications. Withhold UKONIQ for severe (Grade 3) cutaneous reactions until resolution. Monitor at least weekly until resolved. Upon resolution, resume UKONIQ at a reduced dose. Discontinue UKONIQ if severe cutaneous reaction does not improve, worsens, or recurs. Discontinue UKONIQ for life-threatening cutaneous reactions or SJS, TEN, or DRESS of any grade. Provide supportive care as appropriate.
  • Allergic Reactions Due to Inactive Ingredient FD&C Yellow No. 5: UKONIQ contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons, frequently in patients who also have aspirin hypersensitivity.
  • Embryo-fetal Toxicity: Based on findings in animals and its mechanism of action, UKONIQ can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.
  • Serious adverse reactions occurred in 18% of 221 patients who received UKONIQ. Serious adverse reactions that occurred in ≥2% of patients were diarrhea-colitis (4%), pneumonia (3%), sepsis (2%), and urinary tract infection (2%). Permanent discontinuation of UKONIQ due to an adverse reaction occurred in 14% of patients. Dose reductions of UKONIQ due to an adverse reaction occurred in 11% of patients. Dosage interruptions of UKONIQ due to an adverse reaction occurred in 43% of patients.
  • The most common adverse reactions (>15%), including laboratory abnormalities, in 221 patients who received UKONIQ were increased creatinine (79%), diarrhea-colitis (58%, 2%), fatigue (41%), nausea (38%), neutropenia (33%), ALT increase (33%), AST increase (32%), musculoskeletal pain (27%), anemia (27%), thrombocytopenia (26%), upper respiratory tract infection (21%), vomiting (21%), abdominal pain (19%), decreased appetite (19%), and rash (18%).
  • Lactation: Because of the potential for serious adverse reactions from umbralisib in the breastfed child, advise women not to breastfeed during treatment with UKONIQ and for at least one month after the last dose.
Please see full Prescribing Information.

References: 1. UKONIQ [prescribing information]. New York, NY: TG Therapeutics; 2021. 2. TG Therapeutics, Inc. data on file.

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