Ukoniq for marginal zone lymphoma and follicular lymphoma, FDA has approved
The FDA ( Food and Drug Administration ) has granted accelerated approval to Ukoniq ( Umbralisib ), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications:
a) adult patients with relapsed or refractory marginal zone lymphoma ( MZL ) who have received at least one prior anti-CD20-based regimen;
b) adult patients with relapsed or refractory follicular lymphoma ( FL ) who have received at least three prior lines of systemic therapy.
Approval was based on two single-arm cohorts of an open-label, multi-center, multi-cohort trial, UTX-TGR-205, in 69 patients with marginal zone lymphoma who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 patients with follicular lymphoma after at least 2 prior systemic therapies.
Patients received Umbralisib 800 mg orally once daily until disease progression or unacceptable toxicity.
Efficacy was based on overall response rate ( ORR ) and duration of response ( DOR ) using modified 2007 International Working Group criteria assessed by an independent review committee.
For patients with marginal zone lymphoma, the ORR was 49% ( 95% CI: 37.0, 61.6 ) with 16% achieving complete responses.
Median DOR was not reached ( 95% CI: 9.3, NE ) in these patients.
For patients with follicular lymphoma, the ORR was 43% ( 95% CI: 33.6, 52.2 ) with 3% achieving complete responses.
Median DOR was 11.1 months ( 8.3, 16.4 ).
The most common ( more than 15% ) adverse reactions, including laboratory abnormalities, were increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.
Serious adverse reactions occurred in 18% of patients, most often from diarrhea-colitis and infection.
Diarrhea-colitis and transaminase elevation were the most common reasons for dose modifications.
The recommended Umbralisib dose is 800 mg taken orally once daily with food until disease progression or unacceptable toxicity. ( Xagena )
Source: FDA, 2021
Updated data from GARNET cohort F evaluating Dostarlimab in mismatch repair-deficient ( dMMR ) non-endometrial advanced solid cancers were presented at...
Rinvoq for the treatment of psoriatic arthritis and ankylosing spondylitis, approved by European Commission
The European Commission ( EC ) has approved Rinvoq ( Upadacitinib, 15 mg ), an oral, once daily selective and...
Opdivo in combination with Cabometyx as first-line treatment for patients with advanced renal cell carcinoma, approved by FDA
The FDA ( U.S. Food and Drug Administration ) has approved Opdivo ( Nivolumab ) 240 mg injection for intravenous...
Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma, approved by European Commission
The European Commission ( EC ) has approved Bavencio ( Avelumab ) as monotherapy for the first-line maintenance treatment of...
EMA ( European Medicines Agency ) has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus...
Xalkori for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma, approved by FDA
The Food and Drug Administration ( FDA ) has approved Xalkori ( Crizotinib ) for pediatric patients 1 year of...
Keytruda as first-line treatment in adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer, approved by European Commission
The European Commission has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of...
FDA has approved Breyanzi ( Lisocabtagene maraleucel ), a new CAR T cell therapy for adults with relapsed or refractory large B-cell lymphoma
The U.S. Food and Drug Administration ( FDA ) has approved Breyanzi ( Lisocabtagene maraleucel; Liso-cel ), a CD19-directed chimeric...
FDA has approved Tepmetko, an oral MET inhibitor for patients with metastatic non-small cell lung cancer and METex14 skipping alterations
The FDA ( US Food and Drug Administration ) has approved Tepmetko ( Tepotinib ) for the treatment of adult...
CHRYSALIS study: Amivantamab has shown clinical activity and durable responses in patients with metastatic or unresectable non-small cell lung cancer and EGFR exon 20 insertion mutations
New data from the phase 1 CHRYSALIS study, which has evaluated Amivantamab in patients with metastatic or unresectable non-small cell...