Αρχική World News FDA Grants Accelerated Approval to Umbralisib for Marginal Zone and Follicular Lymphomas

FDA Grants Accelerated Approval to Umbralisib for Marginal Zone and Follicular Lymphomas

On 5 February 2021, the US Food and Drug Administration (FDA) granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications:

  • Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen;
  • 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-centre, multi-cohort study, UTX-TGR-205 (NCT02793583), in 69 patients with MZL who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 patients with FL 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 MZL, the ORR was 49% (95% confidence interval [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 FL, 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 (>15%) adverse reactions, including laboratory abnormalities, were increased creatinine, diarrhoea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anaemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash. Serious adverse reactions occurred in 18% of patients, most often from diarrhoea-colitis and infection. Diarrhoea-colitis and transaminase elevation were the most common reasons for dose modifications.

The prescribing information provides warnings and precautions for adverse reactions including infections, neutropenia, diarrhoea and non-infectious colitis, hepatotoxicity, and severe cutaneous reactions.

The recommended umbralisib dose is 800 mg taken orally once daily with food until disease progression or unacceptable toxicity.

Full prescribing information for Ukoniq is available here.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review for the MZL indication and orphan drug designation was granted for the treatment of MZL and FL.

The MZL and FL indications were granted accelerated approval based on ORR. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

Source

NEWSLETTER

Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like
57ΑκόλουθοιΑκολουθήστε

Διαβαστε Επίσης

Καρκίνος και Κορωνοϊός (COVID-19) ΜΕΡΟΣ Α

Εάν είστε καρκινοπαθής, το ανοσοποιητικό σας σύστημα μπορεί να μην είναι τόσο ισχυρό όσο κανονικά, έτσι μπορεί να ανησυχείτε για τους κινδύνους που σχετίζονται...

ΠΑΓΚΟΣΜΙΑ ΗΜΕΡΑ ΚΑΡΚΙΝΟΥ

Η Παγκόσμια Ημέρα Κατά του Καρκίνου καθιερώθηκε με πρωτοβουλία της Διεθνούς Ένωσης κατά του Καρκίνου (UICC), που εκπροσωπεί 800 οργανώσεις σε 155 χώρες του...

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ)

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...
- Advertisment -

Ροή Ειδήσεων

Data Shows Women Are Not Getting Access To An Important Part Of Healing After A Mastectomy

Imagine finding out you have breast cancer and need to undergo a mastectomy. But what happens next? How do you move forward after such...

Foodie Friday: It’s Berry Season!

July is National Berry Month! If berries aren’t part of your daily diet, now is the perfect time to start eating more of these...

No Link Between Viral Vector in Zynteglo and Acute Myeloid Leukaemia

On 23 July 2021, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) has endorsed findings of...

Expecting Mom Finds Pregnant Stray Cat And Gives Her A Home

A woman was 9 months pregnant when she found a pregnant stray cat. Unable to bear the thought of the fellow mom giving birth...

3 Questions Cancer Caregivers Can Ask Themselves to Help Prevent Burnout

Karen Warner Schueler is the president of her own executive coaching firm and author of The Sudden Caregiver: A Roadmap for Resilient Caregiving. For...

FDA Approval of Rylaze Will Address Drug Shortage for Childhood ALL

July 29, 2021, by NCI Staff FDA's approval of Rylaze is expected to help address a long-running shortage of the drug Erwinia asparaginase for kids...