Αρχική World News FDA Approves Pralsetinib for RET-Altered Thyroid Cancers

FDA Approves Pralsetinib for RET-Altered Thyroid Cancers

On 1 December 2020, the US Food and Drug Administration (FDA) approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and paediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 

Efficacy was investigated in a multicentre, open label, multi-cohort clinical trial (ARROW, NCT03037385) in patients whose tumours had RET gene alterations. Identification of RET gene alterations was prospectively determined in local laboratories using either next generation sequencing, fluorescence in situ hybridisation, or other tests. 

The main efficacy outcome measures were overall response rate (ORR) and response duration determined by a blinded independent review committee using RECIST v1.1. Efficacy for advanced or metastatic RET-mutant MTC was evaluated in 55 patients who received prior cabozantinib or vandetanib. The ORR for these patients was 60% (95% confidence interval [CI] 46%, 73%); 79% of responding patients had responses lasting 6 months or longer. Efficacy was also evaluated in 29 patients with RET-mutant MTC who did not receive prior cabozantinib or vandetanib. The ORR was 66% (95% CI 46%, 82%); 84% of patients had responses lasting 6 months or longer. Efficacy for patients with RET fusion-positive thyroid cancer was evaluated in 9 patients who were radioactive iodine-refractory. The ORR was 89% (95% CI 52%, 100%); all responding patients had responses lasting 6 months or longer. 

The most common adverse reactions (≥25%) were constipation, hypertension, fatigue, musculoskeletal pain, and diarrhoea. The most common Grade 3-4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased haemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased platelets, and increased alkaline phosphatase. 

The recommended pralsetinib dose in adults and paediatric patients 12 years and older is 400 mg orally once daily on an empty stomach with no food intake for at least 2 hours before and at least 1 hour after taking pralsetinib. 

Full prescribing information for GAVRETO is available here

This review used the Real-Time Oncology Review pilot programme and Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 3 months ahead of the FDA goal date. 

This application was granted accelerated approval based on ORR and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 

This application was granted priority review, breakthrough therapy, 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 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

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...