Venclyxto/Venclexta (venetoclax)

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Venclyxto / Venclexta (venetoclax)

Venclexta / Venclyxto (venetoclax) is a medication used for the treatment of chronic lymphocytic leukemia (CLL) in presence of 17p deletion.

How to buy Venclexta: You can order Venclexta / Venclyxto (venetoclax) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country.

Oncology Leukemia
Marketing Authorisation Holder AbbVie Ltd
Mode of Action BCL-2 inhibitor (chemotherapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia

What is Venclexta / Venclyxto (venetoclax) for?

Venclexta / Venclyxto (venetoclax) is a BCL-2 inhibitor (chemotherapy) indicated for the treatment of people with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior therapy1,8, 9. Venetoclax is marketed in the USA and in Australia under the name Venclexta1,9, and in the European Union under the name Venclyxto8. The presence of 17p deletion can be assessed through the use of specifically designed diagnostic tools3.

How does Venclexta / Venclyxto (venetoclax) work?

CLL is a slow-growing disease in which too many immature lymphocytes (white blood cells) accumulate in the blood and bone marrow2. About 10% of patients with untreated CLL and approximately 20% of patients with relapsed CLL have a particular chromosomal abnormality (17p deletion)3 that is related to a specific type of CLL named B-Cell lymphoma 2 (BCL-2).

Patients with CLL who have a 17p deletion lack a portion of the 17th chromosome where resides a gene involved with the identification and elimination of faulty cells4. This gene acts to suppress cancer growth. In the presence of a 17p deletion, healthy cells are unable to use this identification/elimination pathway to prevent and control malignant cells5.

Venetoclax is a selective inhibitor of a protein, named B-Cell lymphoma 2 (BCL-2 protein), that inhibits cell death (anti-apoptotic protein). Over-expression of BCL-2 protein has been demonstrated in BCL-2 cells where it mediates tumour cell survival and has been associated with resistance to chemotherapeutics. Patients with 17p deletion usually have poor outcomes with conventional chemo-immunotherapy6. Venetoclax is the first approved treatment that helps restore the process of apoptosis (cell death) by binding directly to the BCL-2 protein and preventing the inhibition of cell death1.

Where has Venclexta / Venclyxto (venetoclax) been approved?

Venclexta / Venclyxto (venetoclax) was approved by:

  • Food and Drug Administration (FDA), USA: April 11th, 2016, for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy1.

  • European Medical Agency (EMA), European Union, December 5, 20168

and

  • Therapeutic Goods Administration (TGA), Australia, January 5, 20179

for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion or patients with relapsed or refractory CLL when other medicines are unsuitable or have failed8,9.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Venclexta / Venclyxto (venetoclax) taken?

The standard dosage consists of a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg:

  • Week 1: 20 mg daily.
  • Week 2: 50 mg daily.
  • Week 3: 100 mg daily.
  • Week 4: 200 mg daily
  • Week 5+: 400 mg daily.
  • The starter pack covers the treatment up to week 4. For week 5 and beyond venetoclax is dispensed as a one month supply in a bottle containing 120 100 mg tablets.

Concomitant use with strong inhibitors of CYP3A at initiation and during ramp-up phase is contraindicated1,8,9.

Complete information about Venclexta / Venclyxto (venetoclax) dosage and administration can be found in the official prescribing information listed in our resources section1,8,9.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Venclexta / Venclyxto (venetoclax)?

Common side effects

The most common side effects (≥20%) listed in the prescribing information include1,8,9:

  • neutropenia (neutrophil count decreased)
  • diarrhea
  • nausea
  • anemia
  • upper respiratory tract infection
  • fatigue.
  • Serious adverse reactions

The serious side effects (≥2%) listed in the prescribing information include:

  • pneumonia
  • febrile neutropenia
  • tumour lysis syndrome (TLS).

Use in specific populations

Venclexta / Venclyxto (venetoclax) can be fatal for a fetus, it is advised to avoid pregnancies and breast-feeding.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,8,9.

More Information
Working ingredient venetoclax
Shipping method Standard (not temperature controlled)
Therapeutic Area Oncology
Oncology Leukemia
Indication Chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation
Administration Oral
Mode of Action BCL-2 inhibitor (chemotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder AbbVie Ltd
HS Code N/A
CAS Number N/A

CLL in presence of 17p deletion or TP53 mutation

The European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Venclexta/Venclyxto (venetoclax) for CLL in presence of 17p deletion or TP53 mutation were based on single arm (no comparator), open-label, multi-centre study (M13-982). This study involved 107 patients at first and then 51 patients were additionally included (safety expansion cohort) for a total of 158 patients. Patients continued treatment until disease progression or unacceptable toxicity. The median duration of treatment for 158 patients was 17 months (range: 0 to 34 months)8.

The Food and Drug Administration (FDA), USA, approval was based on an open-label, single-arm, multicenter clinical trial of 106 patients with CLL with 17p deletion who had received at least one prior therapy. In the study, 17p deletion was confirmed using a diagnostic test FDA approved for the selection of patients for venetoclax treatment (Vysis CLL FISH Probe Kit). Patients continued treatment until disease progression or unacceptable toxicity1.

Results

Among the major efficacy outcome measures were the overall response rate (ORR), complete remission and complete remission with incomplete hematological response (CR/CRi), duration of response (DoR), progression-free survival, and time to response (TTR). The results reported here emerged from the data cut-off date 10 June 2016.

The ORR was8:

  • 77% [95 % CI: 69.9, 83.5] in study M13-982

    • CR + CRi: 18%

  • 80.2% [95% CI: 71.3, 87.3] in the study the FDA approval was based on1.

    • CR + CRi: 8%

The DoR was8:

  • (median) 27.5 months [95 % CI: 26.5, not reached] in study M13-982

  • (range) 2.9 to 19.0+ months in the study the FDA approval was based on1.

The median PFS was8:

  • 27.2 months [95 % CI: 21.9, not reached] in study M13-982

The median TTR was8:

  • 1.0 months [range 0.5, 4.4] in study M13-982

  • 0.8 months [range: 0.1, 8.1] in the study the FDA approval was based on1.

CLL in patients who failed a B-cell receptor pathway inhibitor

The European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Venclexta / Venclyxto (venetoclax) for CLL in patients who failed a B-cell receptor pathway inhibitor were based on open-label, multi-center, non-randomised, phase 2 study (M14-032). This study involved 64 patients who relapsed on or were refractory to ibrutinib or idelalisib. Patients continued treatment until disease progression or unacceptable toxicity. The median duration of treatment was 11.7 months (range: 0.1 to 17.9 months)8.

Results

Among the major efficacy outcome measures were the overall response rate (ORR), complete remission and complete remission with incomplete hematological response (CR/CRi), progression-free survival, and time to response (TTR).

The ORR was:

  • 64% [95% CI: 51.1, 75.7)]

    • CR + CRi: 9%

The PFS was:

  • 6-months estimate: 89% [95% CI: 78, 94.5]

  • 12-months estimate: 72% [95% CI: 56.6, 82.4]

The median TTR was:

  • 1.6 months [range 1.6, 11]

CLL in previously treated patients

The Therapeutic Goods Administration (TGA), Australia, approval of Venclexta / Venclyxto (venetoclax) for CLL in previously treated patients was based on an open-label, multi-center study (M12-175). This study involved 57 patients. Patients continued treatment until disease progression or unacceptable toxicity. The median duration of treatment at the time of evaluation was 11.5 months (range: 0.5 - 34.1 months)9.

Results

Among the major efficacy outcome measures were the overall response rate (ORR) and duration of response (DOR).

The ORR was9:

  • 73.7% [95% CI: 60.3, 84.5)]

    • CR + CRi: 7%

The DOR was9:

  • 12-months estimate: 88.8% [95% CI: 67.5, 96.5]

1. Summary of Product Characteristics [FDA]: Venclexta (venetoclax) [PDF]
    AbbVie Inc., Dec 2017

2. Chronic lymphocytic leukemia
    Anticancer Fund, cited Aug 2016

3. FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
FDA News Release, April 2016 

4. 17p Deletion in CLL
    Dr. Sharman's CLL & Lymphoma Blog, Oct 2010

5. What exactly does a 17p deletion mean? 
    Patient Power, cited Aug 2016 

6. Jain N. and O'Brien S. Chronic Lymphocytic Leukemia With Deletion 17p: Emerging Treatment Options.    Oncology Nov 2012

7 Vysis CLL FISH Probe Kit
   Abbott, cited Aug 2016

8. Summary of Product Characteristics [EMA]: Venclyxto (venetoclax) [PDF]
    AbbVie Ltd., Jan 2018

9. Summary of Product Characteristics [TGA]: Venclexta (venetoclax) [PDF]
    AbbVie Ltd., Jan 2017

10. Human Medicines: Venclyxto (venetoclax)
      EMA, cited Jan 2016

Shipping Type Standard
Shipping method Standard (not temperature controlled)
Dynamic Weight No
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Patient reviews

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Patient reviews

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.