Αρχική World News EMA Recommends Refusal of the Marketing Authorisation for Pexidartinib

EMA Recommends Refusal of the Marketing Authorisation for Pexidartinib

The European Medicines Agency (EMA) has recommended the refusal of the marketing authorisation for pexidartinib (Turalio), a medicine intended for the treatment of tenosynovial giant cell tumour.

The Agency issued its opinion on 25 June 2020. The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.

Turalio was developed as a medicine for treating adults with tenosynovial giant cell tumour that can cause pain and markedly reduce physical function. It was for use when other treatments, including surgery, could no longer be used or were unsuitable. Tenosynovial giant cell tumour is a noncancerous condition in which the tissue surrounding the inner joint surfaces and tendons, called the synovial lining or synovium, expands abnormally and forms growths in and around the joint.

Turalio contains the active substance pexidartinib and was to be available as capsules.

Turalio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 March 2015 for the treatment of tenosynovial giant cell tumour, localised and diffuse type.

The active substance in Turalio, pexidartinib, works by blocking a receptor called CSF1R to which a protein called CSF-1 attaches. CSF-1 is produced in large amounts by tenosynovial giant cell tumours, and it causes immune cells called macrophages to build up in the joints and cause the outgrowths. By blocking CSF1R, the medicine reduces the activity of CSF-1, which was expected to prevent tumour growth and help to reduce symptoms of the disease.

To support its application, the company presented results from a main study involving 120 adults with advanced tenosynovial giant cell tumour that could not be treated in other ways. It looked at the change in tumour size after patients received either Turalio or placebo for 25 weeks.

The Agency was concerned that although the main study found that tumours shrank in patients treated with Turalio, there was only a small improvement in symptoms such as pain and the ability to use the joint. It was not clear how long this effect lasts. There was also serious concern about unpredictable, potentially life-threatening effects of Turalio on the liver. Therefore, the Agency’s opinion was that the benefits of Turalio did not outweigh its risks and it recommended refusing marketing authorisation.

The company informed the Agency that there are no consequences for patients in clinical trials or in compassionate use programmes with Turalio.

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

How Does CAR T-Cell Therapy Work in Treating Cancer?

Craig A. Portell, MD, is an Associate Professor of Medicine at the University of Virginia and a member of the UVA Cancer Center in...

Wales: 4 in 10 with possible cancer symptoms didn’t contact GP

New figures show 42.1% of people surveyed in Wales who experienced possible cancer symptoms in the first wave of the pandemic didn’t contact their...

Survey Shows Oncologists Underestimate How Many Cancer Patients Use Alternative Therapies

Many cancer patients use alternative or complementary therapies in conjunction with their main course of treatment, but a new survey shows that many oncologists...

Ground-breaking trial pilots new tests to detect lung cancer earlier

Credit: Southampton Clinical Trials Unit The first participants have taken part in a new research trial that aims to save lives by detecting lung cancer...

Efficacy and Safety of Patritumab Deruxtecan in EGFR-mutated NSCLC Resistant to EGFR TKI Therapy

Patritumab deruxtecan (HER3-DXd), an antibody drug conjugate consisting of a fully human monoclonal antibody to HER3 attached to a topoisomerase I inhibitor payload via...

This Harmful Chemical Is Still Being Used In Popular Household Products

A dangerous chemical substance is being used in common household products. It’s been linked to myriad health issues in adults, children, and even unborn...