Αρχική World News FDA Approves Crizotinib for Children and Young Adults with Relapsed or Refractory,...

FDA Approves Crizotinib for Children and Young Adults with Relapsed or Refractory, Systemic ALK-positive Anaplastic Large Cell Lymphoma

On 14 January 2021, the US Food and Drug Administration (FDA) approved crizotinib (Xalkori, Pfizer Inc.) for paediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Efficacy was evaluated in Study ADVL0912 (NCT00939770), a multicentre, single-arm, open-label study in patients 1 to ≤21 years of age that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment. Patients received crizotinib 280 mg/m(20 patients) or 165 mg/m2 (6 patients) orally twice daily until disease progression or unacceptable toxicity. Patients were permitted to discontinue crizotinib to undergo haematopoietic stem cell transplantation.

Efficacy was based on objective response rate (ORR) and duration of response as assessed by an independent review committee. The ORR in the 26 patients was 88% (95% confidence interval 71, 96), with a complete remission rate of 81%. Of the 23 patients who achieved a response, 39% maintained response for at least 6 months, and 22% maintained response for at least 12 months.

Ocular toxicity (Grade 1 or 2 visual disorders) occurred in 65% of patients with ALCL, gastrointestinal toxicity occurred in 92%, and serious adverse reactions occurred in 35%, most often from neutropenia and infection. The most common adverse reactions (≥35%), excluding laboratory abnormalities, were diarrhoea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3-4 laboratory abnormalities (≥15%) were neutropenia, lymphopenia, and thrombocytopenia.

The recommended crizotinib dosage for systemic ALCL is 280 mg/m2 orally twice daily based on body surface area. Antiemetics are recommended prior to and during treatment with crizotinib in patients with ALCL. Due to the risk of visual loss, ophthalmologic evaluations are recommended at baseline and serially thereafter, coupled with monthly assessments of visual acuity and visual symptoms.

Full prescribing information for Xalkori is available here.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review, breakthrough designation 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

Overall Breast Cancer Incidence Down Since 1999, Rates Increase for Women Under 40

U.S. breast cancer death rates decreased by about 1% per year between 2013 and 2018. What were the new case rates during that same...

Impressive Responses to PD-1 Blockade in a Large Cohort of Children and Young Adults with Recurrent/Progressive Germline DNA Replication Repair-Deficient Cancers

A large, observational, registry-based study that leveraged systematically collected data gathered both retrospectively and prospectively through the International Replication Repair Deficiency Consortium reveals impressive...

2-Year-Boy Is So Excited To See Himself In Disney’s ‘Encanto’

The importance of representation in media has been a growing topic of concern, and companies have responded by adding more diversity to their characters,...

Man Walks Entire Continent To Spread Awareness About Mental Health & Suicide Prevention

Matthew Fennell is walking over 3,000 miles across Australia for an important cause and one that is near and dear to his heart. Last year,...

Boy Battling Cancer Becomes Honorary Police Officer, Sworn In To 45 Agencies

At just ten years old, Devarjaye “DJ” Daniel has already been through more than most people go through in their entire lives. DJ has been...

Paclitaxel and Carboplatin Not Inferior When Compared with Paclitaxel and Ifosfamide for the Treatment of Patients with Uterine Carcinosarcoma

With regard to overall survival (OS), paclitaxel and carboplatin was not inferior and demonstrated improved progression-free survival (PFS) when compared with paclitaxel and ifosfamide...