Hundreds of people are set to benefit after NICE recommended
acalabrutinib for newly diagnosed mantle cell lymphoma and
chronic lymphocytic leukaemia today (Thursday 6
August.)
Mantle cell lymphoma
Acalabrutinib, combined with bendamustine and rituximab, is
recommended in NICE's final draft guidance as an
option for around 350 adults with untreated
mantle cell lymphoma (MCL) who are not eligible
for a stem cell transplant.
MCL is a rare and aggressive type of non-Hodgkin
lymphoma. It is considered incurable with current treatments
and often comes
back. Many people are diagnosed when the
disease is at an advanced stage and often are not
well enough to have a stem cell transplant, which
limits their options.
Clinical evidence showed that adding acalabrutinib to
bendamustine and rituximab significantly increased the time
before the condition worsened to 72.5 months, compared with
47.8 months for standard treatment alone.
A patient expert involved in the
evaluation told the independent
committee about the shock and distress of receiving an
incurable diagnosis. They explained that because many people have
limited options once the disease progresses, having access to the
best possible first-line treatment can be essential to extending
time before relapse. The committee heard that having more
first-line options available could help people feel more
confident about their treatment journey.
Chronic lymphocytic leukaemia
NICE has also recommended acalabrutinib in combination with
venetoclax, without obinutuzumab, as an option for adults with
untreated chronic lymphocytic leukaemia (CLL) with around
440 set to benefit.
CLL is the most common type of leukaemia in adults
in England. It usually progresses slowly
but can have a significant physical and psychological impact
on daily life. Patient experts told
the independent committee that treatment
preference is shaped by individual circumstances, including
work, family life and the burden of frequent
hospital visits.
Evidence from the AMPLIFY trial showed that acalabrutinib plus
venetoclax improved progression-free survival and overall
survival compared with standard chemoimmunotherapy.
Unlike some treatments for this type of cancer,
acalabrutinib plus venetoclax is taken as a daily
pill rather than by intravenous infusion, meaning
it may be easier for some people to fit treatment around
daily life and can mean fewer hospital trips. Clinical
experts on the committee said it was generally
well tolerated by people, which could make it a
suitable option for a broader range of people,
including older, fitter patients.
Helen Knight, director of medicines evaluation at
NICE said: "Being diagnosed with mantle
cell lymphoma or chronic lymphocytic
leukaemia can have a profound physical and
psychological impact on people and their families.
"People tell us about the anxiety of waiting to see
if a treatment will
work, and what might come next. These
recommendations give people further treatment
options that can help extend the time before
their cancer gets worse, while also fitting more easily
around their daily life."
Ruth Lester, patient representative from Lymphoma Action,
living with mantle cell lymphoma said: "I still
remember the feeling of total shock when I was diagnosed, after
18 months of unexplained infections. At first, I was put on watch
and wait', as I was too well to start treatment, and later,
when treatment became necessary, at the age of 65, I made the
difficult decision not to have a stem cell transplant. Instead, I
had treatment with bendamustine and rituximab, followed by
maintenance therapy. It hasn't been straightforward
- I've dealt with complications along the way,
including problems with my immune system and my lungs. But 13
years on, I'm still here - living well, working as
a trustee and playing the piano.
That's why this decision matters so much. It's very encouraging
to hear that a new and better tolerated treatment option has been
recommended which should mean some MCL patients can enjoy a
longer time with a better quality of life."
