Αρχική World News Moxetumomab Approved by FDA for Hairy Cell Leukemia

Moxetumomab Approved by FDA for Hairy Cell Leukemia

September 14, 2018, by NCI Staff

Moxetumomab pasudotox (Moxe) binds CD22 receptors on the surface of cancerous B cells, where it is internalized and processed to release its toxic payload.

Credit: National Cancer Institute

The Food and Drug Administration (FDA) has approved moxetumomab pasudotox (Lumoxiti), a bacterial toxin–based drug, for the treatment of some patients with hairy cell leukemia (HCL). The approval covers the use of moxetumomab in patients with HCL who have already undergone at least two lines of standard treatments.

The action by FDA makes moxetumomab the first treatment approved for this group of patients. The approval was based on the findings from an 80-patient clinical trial sponsored by the drug’s manufacturer, MedImmune. 

In the trial, approximately 30% of patients had a complete disappearance of their cancer (complete response) that lasted for a long period, and side effects from the therapy were few and mostly minor. Overall, 75% of patients in the trial had either a partial response or complete response.

Moxetumomab was originally discovered by Ira Pastan, M.D., and colleagues in NCI’s Center for Cancer Research (CCR), and later licensed to MedImmune/AstraZeneca for clinical development. 

“This is an important example of conceptually innovative research conducted at NCI that has come to practical fruition with a commercial partner,” said CCR Director Tom Misteli, Ph.D. “It’s the kind of work made possible by our ability at NCI to pursue long-term, high-risk research, including on rare forms of cancers such as hairy cell leukemia. Moxetumomab will make a difference in the lives of patients with this incurable disease.”

Many people diagnosed with HCL will achieve remission with current treatments, explained the trial’s lead investigator, Robert Kreitman, M.D., of CCR’s Laboratory of Molecular Biology.

“But about 30%–40% of those patients will relapse 5 to 10 years after their first treatment,” Dr. Kreitman continued.

As patients receive further treatments, although they may go into remission again, the length of those remissions gets shorter and shorter, and the toxicities of the treatments accumulate, he explained. For these patients, few effective treatments exist, which is what makes this new approval so important.

“Moxetumomab represents a promising nonchemotherapeutic treatment for HCL, addressing an unmet medical need for patients,” Dr. Kreitman said.

Moxetumomab includes a special boxed warning for clinicians and patients about the risk of capillary leak syndrome, in which fluid and proteins leak out of tiny blood vessels into surrounding tissues.

Further details on moxetumomab and the clinical trial on which FDA’s approval was based are available in this June 2018 Cancer Currents post.

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

Nurse Who Battled Cancer While In School Surprises Her Dad With News That She’s Cancer-Free

Victoria Glosson has always been a fighter. She enrolled in nursing school so she could fight and advocate for those in need, and the...

Encouraging Early Results Seen with Novel MEDI1191 in Advanced Tumours

Early results from a phase I study showed promising safety, tolerability, and efficacy following sequential intratumoural (IT) administration of MEDI1191, an IL-12 mRNA agent,...

Multiple Myeloma Awareness Month: Inequity and Disparities in Multiple Myeloma Diagnosis, Treatment and Survivorship

March is Multiple Myeloma Action Month. This blog series will feature facts about this blood cancer as well as voices from the myeloma patients...

EMA Recommends Granting a Conditional Marketing Authorisation for Dostarlimab

On 25 February 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting...

Rare Disease Day: Raising Awareness for Rare Cancers

Every year on the last day of February, the world recognizes rare diseases—a day now known as Rare Disease Day. Rare diseases affect approximately 25...

Oncotype DX Breast Cancer Test May Be Less Accurate for Black Patients

February 26, 2021, by NCI Staff A sample of an Oncotype DX Breast Recurrence Score report. Credit: Adapted from image provided courtesy of Genomic Health The Oncotype...