Αρχική World News EMA Recommends Granting a Marketing Authorisation Under Exceptional Circumstances for Moxetumomab Pasudotox

EMA Recommends Granting a Marketing Authorisation Under Exceptional Circumstances for Moxetumomab Pasudotox

On 10 December 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product moxetumomab pasudotox (Lumoxiti), intended for the treatment of relapsed or refractory hairy cell leukaemia.

The applicant for this medicinal product is AstraZeneca AB.

Lumoxiti will be available as 1-mg powder (with stabiliser solution) for concentrate for solution for infusion. The active substance of Lumoxiti is moxetumomab pasudotox, an antineoplastic agent (ATC code: L01XC34). Moxetumomab pasudotox is a CD22-targeted immunotoxin designed to direct the cytotoxic action of the truncated Pseudomonas exotoxin to cells which express the CD22 receptor.

The benefit with Lumoxiti is its ability to provide a durable response in patients with relapsed or refractory hairy cell leukaemia.

The most common side effects are peripheral oedema, nausea, fatigue, headache, and pyrexia. Important identified risks are haemolytic uraemic syndrome and capillary leak syndrome.

The full indication is:

Lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue.

Lumoxiti should be prescribed by physicians experienced in the use of anticancer medicinal products.

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.

In exceptional circumstances, an authorisation may be granted subject to certain specific obligations, to be reviewed annually. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicinal product, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

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

Mothers Raise Girls Together After Discovering They Were Swapped At Birth

On New Years’ Even in 1998, two baby girls were born at a hospital in a Sicilian fishing port, Mazara del Vallo. The babies were...

Firefighters Band Together To Raise $30k For Breast Cancer Research & Care

Firefighters save lives as part of their job, but this group of firefighters are deemed heroes for more than just their firefighter duties. When they...

Foodie Friday: Butternut Squash Macaroni Casserole

As we move into fall, grocery stores and farmer’s markets are moving beautiful, health-filled butternut squash to their produce sections! When I saw this recipe...

Extra or Missing Chromosomes May Help Cancer Cells Survive Treatment

September 24, 2021, by NCI Staff Most healthy human cells have 23 pairs of chromosomes, 1 through 22, plus X and Y. Many cancer cells,...

A winding journey into the world of children’s and young people’s cancer research

“It seems strange trying to describe my career path, as the words imply that there was some sort of intention or plan as to...

Early Signs of Efficacy of New Targeted Agents and Immunotherapies Reported for Multiple Cancers at ESMO Congress 2021 [ESMO Congress 2021 Press Release]

LUGANO, Switzerland – Data from early clinical trials presented at the ESMO Congress 2021 suggest that new anticancer treatments are on the horizon, with...