Αρχική World News FDA Grants Regular Approval to Venetoclax in Combination for Untreated Acute Myeloid...

FDA Grants Regular Approval to Venetoclax in Combination for Untreated Acute Myeloid Leukaemia

On 16 October 2020, the US Food and Drug Administration (FDA) granted regular approval to venetoclax (VENCLEXTA ®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.

Venetoclax was initially granted accelerated approval for this indication in November 2018.

Efficacy was confirmed in two randomised, double-blind, placebo-controlled studies in patients with AML described above.

In VIALE-A (NCT02993523), patients were randomised to receive venetoclax plus azacitidine (n=286) or placebo plus azacitidine (n=145). Efficacy was established based on an improvement in overall survival (OS). The median OS was 14.7 months (95% confidence interval [CI] 11.9, 18.7) in patients treated with venetoclax plus azacitidine compared to 9.6 months (95% CI 7.4, 12.7) in those receiving placebo plus azacitidine (hazard ratio [HR] 0.66; 95% CI 0.52, 0.85; p < 0.001). Patients treated with venetoclax plus azacitidine also demonstrated an improvement in complete remission (CR) rate: 37% (95% CI 31%, 43%) versus 18% (95% CI 12%, 25%).

In VIALE-C (NCT03069352), patients were randomised to receive venetoclax plus LDAC (n=143) or placebo plus LDAC (n=68). Efficacy was based on CR rate and duration of CR. The CR rate on the venetoclax plus LDAC arm was 27% (95% CI 20%, 35%) with a median duration of 11.1 months (95% CI 6.1, not reached) compared to 7.4% (95% CI 2.4%, 16%) with a median duration of 8.3 months (95% CI 3.1, not reached) in those receiving placebo plus LDAC. Venetoclax plus LDAC did not significantly improve OS versus placebo plus LDAC (HR 0.75; 95% CI 0.52, 1.07; p = 0.114). 

The most common adverse reactions of venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine (≥30% in any trial) were nausea, diarrhoea, thrombocytopenia, constipation, neutropenia, febrile neutropenia, fatigue, vomiting, oedema, pyrexia, pneumonia, dyspnoea, haemorrhage, anaemia, rash, abdominal pain, sepsis, musculoskeletal pain, dizziness, cough, oropharyngeal pain, and hypotension.

The recommended venetoclax dose depends upon the combination regimen and is described in prescribing information. Full prescribing information for VENCLEXTA 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, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.

This review used the Real-Time Oncology Review pilot programme and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 5 weeks ahead of the FDA goal date.

FDA granted this application 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 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

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...

Prostate Cancer

The article is provided by Scientific Communications Officer of NIPD Genetics, Ms Marina Charitou (MSc) Prostate Cancer Awareness Prostate cancer is the second most common cancer...
- Advertisment -

Ροή Ειδήσεων

FDA Grants Accelerated Approval to Naxitamab for High-Risk Neuroblastoma in Bone or Bone Marrow

On 24 November 2020, the US Food and Drug Administration (FDA) granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage...

Genetic Cancer Screenings in Younger Women May Be Cost-Effective and Lead to Fewer Cases

Many women may wonder if they have genetic mutations that make them more apt to develop breast and ovarian cancers. Is it worth it...

After Battling Breast Cancer and Infertility, Mom Welcomes Miracle Baby

At 31-years-old, and during the week of her daughter’s first birthday, Gemma Isaacs received shocking news. Not only did her doctor confirm that she...

“Selfless and Incredible” Mother Leaves Behind Five Children After Battling Breast Cancer

Hollie Jobber spent her life protecting and caring for children, both her own and those most in need. The 35-year-old mother of five worked...

Spending Review 2020 – Steps in the right direction, but opportunities missed

Today, the Chancellor Rishi Sunak set out the UK Government’s spending priorities for the next year. It was an opportunity to lay the groundwork for...

Coping With the Holidays During COVID-19 and Cancer

As we prepare for the holidays this year, we face a new challenge that forces us to rethink plans and possibly even cancel them....