Venclyxto
Active
Substance: venetoclax
Common Name: venetoclax
ATC Code: L01XX52
Marketing Authorisation Holder: AbbVie Ltd
Active Substance: venetoclax
Status: Authorised
Authorisation Date: 2016-12-05
Therapeutic Area: Leukemia, Lymphocytic, Chronic, B-Cell
Pharmacotherapeutic Group: Antineoplastic agents
Therapeutic
Indication
Venclyxto
monotherapy is indicated for the treatment of chronic lymphocytic leukaemia
(CLL) in the presence of 17p deletion or TP53 mutation in adult patients who
are unsuitable for or have failed a B cell receptor pathway inhibitor.
Venclyxto
monotherapy is indicated for the treatment of CLL in the absence of 17p
deletion or TP53 mutation in adult patients who have failed both
chemoimmunotherapy and a B cell receptor pathway inhibitor.
What is
Venclyxto and what is it used for?
Venclyxto is a
medicine for treating a blood cancer known as chronic lymphocytic leukaemia
(CLL) when other treatments have failed or are unsuitable.
In patients with
particular genetic changes (17p deletion or TP53 mutation)
that make them unsuitable for chemo-immunotherapy, Venclyxto is used when
medicines known as B‑cell receptor pathway inhibitors (ibrutinib and
idelalisib) are not suitable or have failed.
In patients who
do not have these genetic changes, Venclyxto is used after treatments with
chemo-immunotherapy and a B‑cell receptor pathway inhibitor has failed.
Because the
number of patients with CLL is low, the disease is considered ‘rare’, and
Venclyxto was designated an ‘orphan medicine’ (a medicine used in rare
diseases) on 6 December 2012.
Venclyxto
contains that active substance venetoclax.
How is Venclyxto
used?
Venclyxto is
available as tablets to be taken by mouth once a day with a meal. The starting
dose is 20 mg daily and the dose is gradually increased over 5 weeks to
400 mg. The patient should stay on treatment for a long as the patient
improves or remains stable and the side effects are tolerable. If the patient
experiences certain side effects, treatment may be stopped temporarily or the
dose reduced.
Venclyxto should
be started and supervised by a doctor with experience of cancer medicines and
can only be obtained with a prescription.
How does
Venclyxto work?
The active
substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2. This
protein is present in high amounts in CLL cancer cells, where it helps the
cells survive for longer in the body and makes them resistant to cancer
medicines. By attaching to Bcl-2 and blocking its actions, venetoclax causes
the death of cancer cells and thereby slows the progression of the disease.
What benefits of
Venclyxto have been shown in studies?
Studies have
shown that a high proportion of patients have their cancer cells partially or
completely cleared following treatment with Venclyxto. In a main study of 107
previously treated patients with CLL and 17p deletion, 75% responded partially
or completely to Venclyxto. In another study of 64 patients with or without 17p
deletion or TP53 mutation, the response rate was 67%. Patients in
this second study had all previously taken B‑cell receptor pathway inhibitors.
What are the
risks associated with Venclyxto?
The most common
side effects with Venclyxto (seen in more than 1 in 5 people) are reduced
neutrophils (a type of white blood cell), diarrhoea, nausea, anaemia (low red
blood cell counts), nose and throat infection, tiredness, high levels of
phosphate in the blood, vomiting and constipation.
The most common
serious side effects (seen in more than 2 in 100 people) are pneumonia (lung
infection), fever associated with reduced neutrophils and tumour lysis syndrome
(a complication caused by breakdown of cancer cells). For the full list of side
effects reported with Venclyxto, see the package leaflet.
Venclyxto must
not be used with medicines known as ‘strong CYP3A inhibitors’ during the early
stages of treatment and must also not be used with St. John’s wort (a herbal
preparation used to treat anxiety and depression).
Why is Venclyxto
approved?
A high
proportion of patients respond to Venclyxto after other treatments have failed
or are unsuitable.Studies showed patients with particular genetic mutations
(17p deletion or TP53 mutations) that make them
unsuitable for chemo-immunotherapy responding well to treatment. In addition, a
high response rate was seen in patients whose previous treatment with ibrutinib
or idelalisib failed.
Regarding
safety, the medicine’s side effects are considered acceptable. Although there
is a risk of tumour lysis syndrome, a complication that occurs when the cancer
cells are being destroyed too quickly, this risk can be contained through
preventive measures, such as increasing the dose gradually or reducing the
dose, if needed.
The Agency’s
Committee for Medicinal Products for Human Use (CHMP) noted that although a
small number of patients have been studied so far Venclyxto's benefits outweigh
its risks and recommended its approval in the EU.
Venclyxto has
been given ‘conditional approval’. This means that there is more evidence to
come about the medicine. Every year, the European Medicines Agency will review
any new information that becomes available and this summary will be updated as
necessary.
What information
is still awaited for Venclyxto?
As Venclyxto has
been granted a conditional approval, the company that markets the medicine will
provide further data on its benefits and risks from an ongoing study of
patients whose previous treatment with ibrutinib or idelalisib had failed.
What measures
are being taken to ensure the safe and effective use of Venclyxto?
The company that
markets Venclyxto will provide more data on the medicine’s overall safety.
Recommendations and precautions to be followed by healthcare professionals and
patients for the safe and effective use of Venclyxto have also been included in
the summary of product characteristics and the package leaflet.
Other information
about Venclyxto
The European
Commission granted a conditional marketing authorisation valid throughout the
European Union for Venclyxto on 5 December 2016.
For more
information about treatment with Venclyxto, read the package leaflet (also part
of the EPAR) or contact your doctor or pharmacist.
The summary of
the opinion of the Committee for Orphan Medicinal Products for Venclyxto can be
found on the Agency’s website.
Source: European
Medicines Agency
