Αρχική World News FDA Approves Avelumab for Urothelial Carcinoma Maintenance Treatment

FDA Approves Avelumab for Urothelial Carcinoma Maintenance Treatment

On 30 June 2020, the US Food and Drug Administration (FDA) approved avelumab (BAVENCIO, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

Efficacy of avelumab for maintenance treatment of UC was investigated in the JAVELIN Bladder 100 trial (NCT02603432), a randomised, multicentre, open-label trial that enrolled 700 patients with unresectable, locally advanced or metastatic urothelial carcinoma that had not progressed with four to six cycles of first-line platinum-containing chemotherapy. Patients were randomised (1:1) to receive either avelumab intravenously every 2 weeks plus best supportive care (BSC) or BSC alone. Treatment was initiated within 4-10 weeks after last chemotherapy dose.

The main efficacy outcome measures were overall survival (OS) in all patients and in patients with PD-L1-positive tumours. The median OS in all patients was 21.4 months in the avelumab arm and 14.3 months in the BSC alone arm (hazard ratio [HR] 0.69; 95% CI 0.56, 0.86; p = 0.001). Among patients with PD-L1-positive tumours (51%), the HR for OS was 0.56 (95% CI 0.40, 0.79; p < 0.001). In an exploratory analysis of patients with PD- L1- negative tumours (39%), the HR for OS was 0.85 (95% CI 0.62, 1.18).

The most common adverse reactions in >20% of patients who received avelumab were fatigue, musculoskeletal pain, urinary tract infection, and rash. One patient died from sepsis and 28% of patients had serious adverse reactions.

The recommended avelumab dose is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

The results from this study supported the conversion of accelerated approval of avelumab to a regular approval.

Full prescribing information for BAVENCIO is available here.

This review used Real-Time Oncology Review, which streamlined data submission prior to the filing of the entire clinical application, and also used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was approved 3 months prior to the FDA goal date.

Avelumab was granted priority review and breakthrough therapy designation in this setting.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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...