Αρχική World News EMA Recommends Granting a Marketing Authorisation for Phesgo (Pertuzumab / Trastuzumab)

EMA Recommends Granting a Marketing Authorisation for Phesgo (Pertuzumab / Trastuzumab)

On 12 November 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 Phesgo (Pertuzumab / Trastuzumab), intended for the treatment of early and metastatic breast cancer.

The applicant for this medicinal product is Roche Registration GmbH.

Phesgo will be available as a solution for injection (600 mg / 600 mg and 1200 mg / 600 mg). The active substances of Phesgo are pertuzumab and trastuzumab, two monoclonal antibodies (ATC code: L01XY02) targeting the human epidermal growth factor receptor 2 (HER2), disrupting HER2 signalling, and also mediating antibody-dependent cell-mediated cytotoxicity.

The benefit of Phesgo is that it is administered as a subcutaneous, fixed-dose combination of pertuzumab and trastuzumab, offering patients a less invasive and faster administration as a single product, compared to the current administration of the approved intravenous pertuzumab and subcutaneous trastuzumab formulations.

The most common side effects are alopecia, diarrhoea, nausea, anaemia, asthenia, and arthralgia.

The full indication is:

Early breast cancer (EBC)

Phesgo is indicated for use in combination with chemotherapy in:

  • the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
  • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.

Metastatic breast cancer (MBC)

  • Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Phesgo should be prescribed by physicians experienced in the administration of anti-cancer agents.

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.

Source

NEWSLETTER

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

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like
57ΑκόλουθοιΑκολουθήστε

Διαβαστε Επίσης

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...

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 Grants Accelerated Approval to Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow

On 24 November 2020, the US Food and Drug Administration (FDA) granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage...

Genetic Cancer Screenings in Younger Women May Be Cost-Effective and Lead to Fewer Cases

Many women may wonder if they have genetic mutations that make them more apt to develop breast and ovarian cancers. Is it worth it...

After Battling Breast Cancer and Infertility, Mom Welcomes Miracle Baby

At 31-years-old, and during the week of her daughter’s first birthday, Gemma Isaacs received shocking news. Not only did her doctor confirm that she...

“Selfless and Incredible” Mother Leaves Behind Five Children After Battling Breast Cancer

Hollie Jobber spent her life protecting and caring for children, both her own and those most in need. The 35-year-old mother of five worked...

Spending Review 2020 – Steps in the right direction, but opportunities missed

Today, the Chancellor Rishi Sunak set out the UK Government’s spending priorities for the next year. It was an opportunity to lay the groundwork for...

Coping With the Holidays During COVID-19 and Cancer

As we prepare for the holidays this year, we face a new challenge that forces us to rethink plans and possibly even cancel them....