Αρχική World News EMA Recommends Extension of Indications for Atezolizumab

EMA Recommends Extension of Indications for Atezolizumab

On 17 September 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product atezolizumab (Tecentriq).

The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted a new indication as follows:

Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have not received prior systemic therapy.

For information, the full indications for Tecentriq will be as follows (new text in bold):

Urothelial carcinoma

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma:

• after prior platinum containing chemotherapy, or

• who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%.

Non-small cell lung cancer

Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.

Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving

Tecentriq.

Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC.

Breast cancer

Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Small cell lung cancer

Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer.

Hepatocellular carcinoma

Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have not received prior systemic therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to 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.

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

Discovering the BRCA2 gene – 25 years on

A breast cancer cell. Credit: LRI EM Unit. 25 years ago, a team of our scientists were celebrating. Their risky strategy had paid off. “You...

Newly Developed RSClin Provides Prognostic Information in HR-positive, HER2-negative Early Breast Cancer

The online RSClin tool incorporating clinical-pathological data and the results of a 21-gene recurrence score (RS) was able to estimate the risk of distant...

Embracing Bravery When You Have a Genetic Cancer Disease

Emily Pinto Billcheck is a licensed social worker with experience in the mental health field. She is a von Hippel-Lindau (VHL) patient who inherited VHL from her...

Chemotherapy Administered for the First Diagnosed Testicular Cancer Reduces the Risk of Metachronous Contralateral Testicular Cancer Occurrence

Patients aged less than 30 years upon diagnosis of testicular cancer and those treated with surgery only are at higher risk of developing a...

New Research Looks for More Effective Breast Cancer Treatments for Black Women

Breast cancer affects people across all different backgrounds, but Black women in particular are more apt to get aggressive forms of the disease. They’re...

Palbociclib Plus Endocrine Therapy Does Not Improve PFS over Capecitabine in HR-positive, HER2-negative Aromatase Inhibitor Resistant Metastatic Breast Cancer

Although patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative, aromatase inhibitor resistant metastatic breast cancer maintained quality of life...