Αρχική World News Withdrawal of Application to Change the Marketing Authorisation for Atezolizumab

Withdrawal of Application to Change the Marketing Authorisation for Atezolizumab

The European Medicines Agency (EMA) announced on 29 January 2021 that Roche Registration GmbH withdrew its application for the use of atezolizumab (Tecentriq) to treat metastatic urothelial cancer in combination with platinum-based therapy in patients who had not been treated before. The company withdrew the application on 8 January 2021.

Tecentriq is already used to treat urothelial cancer, lung cancer, triple-negative breast cancer, and hepatocellular carcinoma. For urothelial cancer, Tecentriq is used on its own in patients who had already received platinum-based chemotherapy or in patients who cannot receive platinum-based therapy and whose cancer cells have a certain amount of PD-L1. Tecentriq has been authorised in the EU since September 2017. The company applied to extend the use of Tecentriq so it can be used in combination with platinum-based chemotherapy as a first-line treatment for advanced or metastatic urothelial cancer.

Tecentriq contains the active substance atezolizumab and is given as an infusion into a vein. Atezolizumab, is a monoclonal antibody designed to recognise and attach to PD-L1, which is present on many cancer cells. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD-L1 and reducing its effects, Tecentriq increases the ability of the immune system to attack the cancer cells and thereby slow down progression of the disease.

To support its application, the company presented data from a main study in around 1,200 patients with advanced or metastatic urothelial cancer who had not been treated before. Patients received either Tecentriq plus gemcitabine in combination with carboplatin or cisplatin (both platinum therapies); placebo plus gemcitabine in combination with carboplatin or cisplatin; or Tecentriq alone. The study looked at progression-free survival and overall survival.

The application was withdrawn after the EMA had evaluated the initial information from the company and had prepared questions for the company. After the Agency had assessed the company’s responses to the questions, there were still some unresolved issues.

Based on the review of the information and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Tecentriq could not have been authorised for the first-line treatment of patients with urothelial cancer in combination with cisplatin.

The Agency noted that the main study could not show that Tecentriq was effective as the different types of patients involved and treatments used made interpreting the results difficult. Data on progression-free survival were not conclusive and those on survival were not statistically significant.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Tecentriq in the first-line treatment of urothelial cancer did not outweigh its risks.

In its letter notifying the Agency of the withdrawal of application, the company stated that it withdrew its application because the Agency could not conclude on a positive benefit-risk balance based on the data provided.

The company informed the Agency that this withdrawal has no consequences for patients in clinical trials using Tecentriq.

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

Combining existing drugs improves prostate cancer survival

Adding abiraterone to standard hormone therapy improves survival for men with high-risk prostate cancer that’s not spread elsewhere in the body. “Today’s results are the...

New Combination of Old Drugs Improves Survival in Patients with Prostate Cancer [ESMO Congress 2021 Press Release]

LBA4_PR - Abiraterone acetate plus prednisolone (AAP) with or without enzalutamide (ENZ) added to androgen deprivation therapy (ADT) compared to ADT alone for men...

Immunotherapy Prolongs Survival in Recurrent, Persistent or Metastatic Cervical Cancer [ESMO Congress 2021 Press Release]

LBA2_PR - Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for persistent, recurrent, or metastatic cervical cancer: Randomized, double-blind, phase 3 KEYNOTE-826 study N. Colombo1, C....

Woman Diagnosed with Breast Cancer at 33 Launches Self-Examination App

Jessica Baladad has had a long history with self-examinations after a breast cancer scare in her early 20s. This habit helped save her life,...

Extended Adjuvant Treatment with Letrozole Results in Longer Survival in Postmenopausal Patients with Breast Cancer

According to results from a prospective, open-label, phase III study conducted in 69 Italian hospitals within the Gruppo Italiano Mammella among the postmenopausal patients...

Foodie Fridays: Apple Bok Choy Salad

While the temps may still be in the 80’s, apple season is upon us! Give this Apple Bok Choy salad a try!  It is...