Αρχική World News FDA Approves Selinexor for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

FDA Approves Selinexor for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

On 22 June 2020, the US Food and Drug Administration (FDA) granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

XPOVIO is a nuclear export inhibitor, available in tablets for oral use.

Approval was based on SADAL (KCP-330-009; NCT02227251), a multicentre, single-arm, open-label trial in patients with DLBCL after 2 to 5 systemic regimens. Patients received selinexor 60 mg orally on days 1 and 3 of each week. 

Efficacy was based on overall response rate (ORR) and response duration, as assessed by an independent review committee using Lugano 2014 criteria. In 134 patients, the ORR was 29% (95% confidence interval 22, 38), with complete response in 13%. Of the 39 patients who achieved a partial or complete response, 38% had response durations of at least 6 months and 15% had response durations of at least 12 months.

The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, were fatigue, nausea, diarrhoea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities in ≥15% were thrombocytopenia, lymphopenia, neutropenia, anaemia, and hyponatremia. Serious adverse reactions occurred in 46% of patients, most often from infection. Thrombocytopenia was the leading cause of dose modifications. Gastrointestinal toxicity developed in 80% of patients and any grade hyponatremia developed in 61%. Central neurological adverse reactions occurred in 25% of patients, including dizziness and mental status changes.

The prescribing information provides warnings and precautions for thrombocytopenia, neutropenia, gastrointestinal toxicity, hyponatremia, serious infection, neurological toxicity, and embryo-foetal toxicity.

The recommended selinexor dosage for patients with DLBCL is 60 mg taken orally on days 1 and 3 of each week with antiemetic prophylaxis.

Full prescribing information for XPOVIO is available here.

This indication was approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

This application was granted priority review and Fast Track designation.

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

Making Important Decisions During Cancer: A Survivor’s Story

Bethany Hart lives with her husband Kevin, sons, and 3 dogs in the suburbs of Indianapolis, Indiana. She is a survivor of small cell neuroendocrine cervical cancer....

Adjuvant Immunotherapy Approved for Some Patients with Lung Cancer

October 26, 2021, by NCI Staff Atezolizumab (Tecentriq) is approved as an additional treatment for some patients with stage II to IIIA (pictured) non-small cell...

Cure Probability Models for Evaluation of Patients with a Previous Cancer Diagnosis for Solid Organ Transplantation

Findings from a first study that applied a formal statistical framework to inform the evaluation of transplant candidates with a previous cancer diagnosis were...

Teacher Reads To Students One Day After Having Brain Surgery

Meucci - who had her surgery on a Wednesday - was going live from her intensive care unit hospital room that very next Thursday...

6 things you need to know about cervical screening

This article was originally published in 2017 during Cervical Screening Awareness Week. It has now been reviewed and updated. Cervical screening, also known as the...

EMA Recommends Granting a Marketing Authorisation for Sacituzumab Govitecan

On 14 October 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting...