Αρχική World News FDA Approves Nivolumab in Combination with Chemotherapy for Metastatic Gastric Cancer and...

FDA Approves Nivolumab in Combination with Chemotherapy for Metastatic Gastric Cancer and Oesophageal Adenocarcinoma

On 16 April 2021, the US Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastro-oesophageal junction cancer, and oesophageal adenocarcinoma.

Efficacy was evaluated in CHECKMATE-649 (NCT02872116), a randomised, multicentre, open-label study that enrolled 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastro-oesophageal junction cancer, or oesophageal adenocarcinoma. PD-L1 combined positive score (CPS) was determined centrally using the Agilent/Dako PD-L1 IHC 28-8 pharmDx test. Patients received nivolumab in combination with chemotherapy (n=789) or chemotherapy alone (n=792); study treatment was administered as follows:

  • Nivolumab 240 mg with mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) every 2 weeks, or mFOLFOX6 every 2 weeks.
  • Nivolumab 360 mg with CapeOX (capecitabine and oxaliplatin) every 3 weeks, or CapeOX every 3 weeks.

The main efficacy outcome measures, assessed in patients with PD-L1 CPS ≥5 (n=955), were progression-free survival (PFS) assessed by blinded independent central review and overall survival (OS).

CHECKMATE-649 demonstrated a statistically significant improvement in PFS and OS for patients with PD-L1 CPS ≥5. Median OS was 14.4 months (95% confidence interval [CI] 13.1, 16.2) in the nivolumab plus chemotherapy arm vs. 11.1 months (95% CI 10.0, 12.1) in the chemotherapy alone arm (hazard ratio [HR] 0.71; 95% CI 0.61, 0.83; p < 0.0001). Median PFS was 7.7 months (95% CI 7.0, 9.2) in the nivolumab plus chemotherapy arm versus 6.0 months (95% CI 5.6, 6.9) in the chemotherapy alone arm (HR 0.68; 95% CI 0.58, 0.79; p < 0.0001).

As an additional efficacy outcome measure, a statistically significant improvement in OS was also demonstrated for all randomised patients (n=1,581) irrespective of CPS, with a median OS of 13.8 months (95% CI 12.6, 14.6) in the nivolumab plus chemotherapy arm vs. 11.6 months (95% CI 10.9, 12.5) in the chemotherapy alone arm (HR 0.80; 95% CI 0.71, 0.90; p = 0.0002).

The most common adverse reactions (incidence ≥20%) observed in patients receiving nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy were peripheral neuropathy, nausea, fatigue, diarrhoea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.

The recommended nivolumab dosages are:

  • 360 mg every 3 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks.
  • 240 mg every 2 weeks in combination with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks.

Full prescribing information for Opdivo is available here.

This review was conducted under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.

This review used the Real-Time Oncology Review [SJ-E3] pilot programme, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application approximately 5 weeks ahead of the FDA goal date.

This application was granted priority review and orphan drug designation.

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 OCE 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

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...