Αρχική World News EMA Recommends Granting a Marketing Authorisation for Melphalan

EMA Recommends Granting a Marketing Authorisation for Melphalan

On 17 September 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 for the medicinal product melphalan (Phelinun), intended for the treatment of certain haematological and other cancers and as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in haematological diseases in adults and children. 

The applicant for this medicinal product is ADIENNE S.r.l. S.U. 

Phelinun will be available as 50-mg and 200-mg powder and solvent for concentrate for solution for infusion. The active substance of Phelinun is melphalan, an anti-neoplastic agent (ATC code: L01AA03) which prevents the separation and replication of DNA, thereby preventing cell replication. 

The benefits of Phelinun from published studies in adults and children include increased overall survival, diseasefree survival, eventfree survival and nonrelapse mortality.  

The most common side effects are myelosuppression and haematological toxicities, gastrointestinal toxicity and immune system disorders. Amenorrhoea, ovarian disorders and premature menopause were also commonly reported. Infections, acute and chronic graft-versus-host disease were reported as the major causes of morbidity and mortality in the allo-HSCT setting.  

Phelinun is a hybrid medicine of Alkeran which has been authorised in the EU since 1996. Phelinun contains the same active substance as Alkeran but is intended for an additional indication based on published literature. 

Studies have demonstrated the satisfactory quality of Phelinun. Since Phelinun is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Alkeran was not required. 

The full indications are: 

High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of: 

  • multiple myeloma 

  • malignant lymphoma (Hodgkin, non-Hodgkin lymphoma) 

  • acute lymphoblastic and myeloblastic leukemia 

  • childhood neuroblastoma 

  • ovarian cancer 

Phelinun in combination with other cytotoxic medicinal products is indicated as RIC treatment prior to allo-HSCT in malignant haematological diseases in adults. 

Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allo-HSCT in haematological diseases in the paediatric population as: 

Phelinun should be prescribed by physicians experienced in the treatment of 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. 

Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. 



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

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like

Διαβαστε Επίσης


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...

Καρκίνος: Ευεργετική για τους καρκινοπαθείς η άσκηση

Σημαντικά ωφέλη προσφέρει η άσκηση, ακόμη και σε ασθενείς με καρκίνο. Οι περισσότεροι ασθενείς αγνοούν τα οφέλη που μπορεί να έχει γι’ αυτούς η συχνή...

Prostate Cancer

The article is provided by Scientific Communications Officer of NIPD Genetics, Ms Marina Charitou (MSc) Prostate Cancer Awareness Prostate cancer is the second most common cancer...
- Advertisment -

Ροή Ειδήσεων

FDA Approves Companion Diagnostic to Identify NTRK Fusions in Solid Tumours for Larotrectinib

On 23 October 2020, the US Food and Drug Administration (FDA) approved the next-generation sequencing (NGS)-based FoundationOne CDx test (Foundation Medicine, Inc.) as a...

An existing blood test for ovarian cancer has been re-evaluated. The results are in.

Ovarian cancer is the sixth most common cancer in women in the UK, with about 7,400 new cases every year. This number equates to...

Teacher Is Glad She Asked for More Testing After Mammogram Failed to Detect Her Breast Cancer

Martha Gray has a long history of breast cancer in her family, so she knows that she needs to take her mammograms seriously every...

How to Stay Healthy After Cancer

I try to pack helpful advice into every follow-up visit I have with patients, focusing on little tips that help foster healthy lifestyles. This...

Feasibility and Preliminary Efficacy Results of the Beat AML Study

Precision medicine in acute myeloid leukaemia (AML) is feasible in terms of providing cytogenetic and mutational data within 7 days, allowing their rapid incorporation into...

Woman Battles Breast Cancer While Pregnant, Delivers Healthy Baby Boy

When she was six months pregnant, Desiree Doughty noticed that something seemed to be wrong with her breasts. “I noticed that one of my breasts...