Αρχική World News FDA Approves Osimertinib as Adjuvant Therapy for NSCLC with EGFR Exon 19...

FDA Approves Osimertinib as Adjuvant Therapy for NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Mutations

On 18 December 2020, the US Food and Drug Administration (FDA) approved osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals LP) for adjuvant therapy after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

Efficacy was demonstrated in a randomised, double-blind, placebo-controlled study (ADAURA, NCT02511106) in patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC who had complete tumour resection, with or without prior adjuvant chemotherapy. Eligible patients with resectable tumours (stage IB – IIIA) were required to have predominantly non-squamous histology and EGFR exon 19 deletions or exon 21 L858R mutations identified prospectively from tumour tissue in a central laboratory by the cobas® EGFR Mutation Test. A total of 682 patients were randomised (1:1) to receive osimertinib 80 mg orally once daily or placebo following recovery from surgery and standard adjuvant chemotherapy, if given.

The major efficacy outcome measure was disease-free survival (DFS) in patients with stage II – IIIA NSCLC determined by investigator assessment. Median DFS was not reached (38.8, Non Estimable [NE]) in patients on the osimertinib arm compared with 19.6 months (16.6, 24.5) on the placebo arm (hazard ratio [HR] 0.17, 95% confidence interval [CI] 0.12, 0.23; p < 0.0001). DFS in the overall study population was a secondary efficacy outcome measure; the median was not reached (NE, NE) in patients on the osimertinib arm compared with 27.5 months (22, 36) on the placebo arm (HR 0.20, 95% CI 0.15, 0.27; p < 0.0001).

The recommended osimertinib dose for adjuvant treatment of early stage NSCLC is 80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years.

Most common (>20%) adverse reactions in patients taking osimertinib, including laboratory abnormalities, were lymphopenia, leukopenia, thrombocytopenia, diarrhoea, anaemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.

Full prescribing information for TAGRISSO is available here.

This review was conducted under Project Orbis, an initiative of the FDA 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 (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, Singapore’s Health Sciences Authority, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.

This review used the Real-Time Oncology Review 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 two months ahead of the FDA goal date.

This application was granted breakthrough 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 OCE’s 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

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...

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...
- Advertisment -

Ροή Ειδήσεων

Final Results of the Collaborative EORTC/Intergroup Randomised Phase III Study of Adjuvant Imatinib in Localised GIST

Final analysis of the EORTC Soft Tissue and Bone Sarcoma Group, the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and...

Pink Van Makes the Rounds Throughout Rural New Zealand to Offer Free Breast Health Advice

Many of us have questions about breast cancer prevention or screenings. Getting lost in a Google rabbit hole can sometimes be overwhelming and could...

How My Inherited Cancer Diagnosis Has Made Me a Better Oncologist

Dr. Lewis is Director of Gastrointestinal Oncology at Intermountain Healthcare Utah; Vice President of American Multiple Endocrine Neoplasia Support; Head of the Communications Committee...

FDA Approves Cemiplimab-rwlc for Advanced Non-Small Cell Lung Cancer With High PD-L1 Expression

On 22 February 2021, the US Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with...

Five-Year Outcomes with CAR T Cell Therapy

The results of 5-year follow-up in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma who were treated with CD19-directed,...

Countdown to 100,000 OncoLife Survivorship Care Plans: How it all started

In April of 2007, OncoLink launched the OncoLife Survivorship Care Plan, a tool to create care plans for people who have survived cancer. As...