A new twice-daily pill that can reduce the risk of cancer
returning has been recommended today by the National Institute
for Health and Care Excellence (NICE) for a type of early breast
cancer. Up to 4000 people may benefit.
Ribociclib (also known by the brand name Kisqali, manufactured by
Novartis), with an aromatase inhibitor is recommended in draft
guidance as an additional treatment option for hormone
receptor-positive, HER2-negative early breast cancer which has
responded to initial treatments including surgery, but where the
cancer has a higher risk of returning.
The treatment will be available from today through interim
funding from the Cancer Drugs Fund
.
The additional treatment option will be available to patients
with cancer that has spread to the lymph nodes and meets at least
one of these criteria:
- Cancer present in at least 4 lymph nodes, or
- Cancer present in 1 to 3 lymph nodes that is either grade 3
(more advanced); or has a primary tumour at least 5cm in size.
The independent appraisal committee found ribociclib with an
aromatase inhibitor was a clinically and
cost-effective treatment for this specific subgroup within the
marketing licence. The committee has asked Novartis for further
evidence for the wider eligible population and a further
committee meeting will be held in June.
For the wider population of people with early breast cancer that
has a higher risk of returning, the committee concluded that the
available cost-effectiveness estimates were not suitable for
decision making in the context of a recommendation for routine
use, because the clinical and economic evidence was too
uncertain.
Ribociclib targets proteins called CDK 4 and CDK 6, which play a
role in cancer cell growth and division. By blocking these
proteins, the treatment helps to slow or stop cancer growth. It
is taken alongside another medicine called an aromatase
inhibitor, which is a hormone therapy that reduces oestrogen
levels in the body.
Clinical trials show that combining ribociclib with an aromatase
inhibitor may extend the time before cancer returns compared
with using an aromatase inhibitor alone.
Novartis has agreed a confidential discount to the NHS on the
standard price of ribociclib, making it a cost-effective
treatment option.
NICE already recommends ribociclib plus fulvestrant as an option
for treating hormone receptor-positive, HER2-negative, locally
advanced or metastatic breast cancer in adults who have had
previous endocrine therapy.
View the full draft guidance
for Ribociclib with an aromatase inhibitor for adjuvant
treatment of hormone receptor-positive, HER2-negative early
breast cancer
