Αρχική World News EMA Recommends Granting a Conditional Marketing Authorisation for Pemigatinib

EMA Recommends Granting a Conditional Marketing Authorisation for Pemigatinib

On 28 January 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product pemigatinib (Pemazyre), intended for the second-line treatment of locally advanced or metastatic cholangiocarcinoma characterised by fusion or rearrangements of fibroblast growth factor receptor 2 (FGFR2).

The applicant for this medicinal product is Incyte Biosciences Distribution B.V.

Pemazyre will be available as 4.5 mg, 9 mg and 13.5 mg tablets. The active substance of Pemazyre is pemigatinib, a protein kinase inhibitor (ATC code: L01EX20) which is a kinase inhibitor of FGFR 1, 2 and 3 that inhibits FGFR phosphorylation and signalling and decreases viability of cells expressing FGFR genetic alterations, including point mutations, amplifications, and fusions or rearrangements.

The benefits with Pemazyre are its ability to increase the number of patients with a complete or partial response after first-line treatment, which is maintained for a median of 8 months.

The most common side effects are hyperphosphataemia, alopecia, diarrhoea, nail toxicity, fatigue, nausea, dysgeusia, stomatitis, constipation, dry mouth, dry eye, arthralgia, hypophosphataemia, dry skin and palmar-plantar erythrodysaesthesia syndrome.

The full indication is:

Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.

Pemazyre should be prescribed by physicians experienced in the diagnosis and treatment of patients with biliary tract cancer.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.  

A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.

This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

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...