Αρχική World News EMA Recommends Granting a Marketing Authorisation for Equidacent

EMA Recommends Granting a Marketing Authorisation for Equidacent

On 23 July 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 Equidacent, a biosimilar bevacizumab, intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer (RCC), epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

The applicant for this medicinal product is Centus Biotherapeutics Europe Limited.

Equidacent will be available as 25 mg/ml concentrate for solution for infusion. The active substance of Equidacent is bevacizumab, a monoclonal antibody (ATC code: L01XC07) which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, thereby inhibiting the binding of VEGF to its receptors on endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.

Equidacent is a biosimilar medicinal product. It is highly similar to the reference product Avastin (bevacizumab), which was authorised in the EU on 12 January 2005.

Data show that Equidacent has comparable quality, safety and efficacy to Avastin.

The full indication is:

  • Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
  • Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, it should be refered to section 5.1.
  • Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Equidacent in combination with capecitabine. For further information as to HER2 status, it should be referred to section 5.1.
  • Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology.
  • Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with epidermal growth factor receptor activating mutations (section 5.1).
  • Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic RCC.
  • Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (section 5.1).
  • Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
  • Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (section 5.1).

Equidacent should be prescribed by physicians experienced in the use of antineoplastic 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 European Commission decision, which will normally be issued 67 days from adoption of the opinion.

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...