The Medicines and Healthcare products Regulatory Agency (MHRA)
has today, 20 June 2025, approved serplulimab (Hetronifly) to
treat adults with extensive-stage small cell lung cancer
(ES-SCLC), which has not previously been treated, and has spread
within the lungs or to other parts of the body.
SCLC is a fast-growing cancer that typically develops in the
airways of the lungs. It accounts for 10-15% of lung cancer cases
and is often diagnosed at a late stage when the cancer has
already spread.
Serplulimab is a monoclonal antibody (a targeted therapy) that
supports the immune system by blocking PD-1, a receptor some
cancer cells use to avoid detection. By inhibiting PD-1, it helps
immune cells recognise and destroy cancer cells more
effectively.
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
“Patient safety is our top priority, which is why I am pleased to
confirm approval of serplulimab to treat extensive-stage small
cell lung cancer.
“As the first and only anti-PD-1 monoclonal antibody approved in
the UK for small cell lung cancer, this marks an important new
treatment option for patients with this aggressive type of lung
cancer who currently have limited choices and face a poor
prognosis.
“We're assured that the appropriate regulatory standards of
safety, quality and efficacy for the approval of this medicine
have been met. As with all products, we will keep its safety
under close review.”
Serplulimab is given by intravenous infusion (into a vein) once
every three weeks, in combination with chemotherapy (carboplatin
and etoposide). Treatment can continue for as long as there is
deemed clinical benefit.
Approval is based on results from a randomised, double-blind
clinical trial involving 585 adults with extensive-stage SCLC who
had not received prior treatment. Participants received either
serplulimab or placebo, alongside chemotherapy.
Patients given serplulimab with chemotherapy lived on average for
15.4 months, compared with 10.9 months for those receiving
chemotherapy and placebo.
A full list of side effects can be found in the Patient
Information Leaflet (PIL) or the Summary of Product
Characteristics (SmPC), available on the MHRA website within 7
days of approval.
As with any medicine, the MHRA will keep the safety and
effectiveness of serplulimab under close review. Anyone who
suspects they are having a side effect from this medicine are
encouraged to talk to their doctor, pharmacist or nurse and
report it directly to the Yellow Card scheme, either through the
website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
-
The new marketing authorisation was granted on 20 June 2025
to Accord Healthcare Limited.
-
This product was submitted and approved via an international
recognition procedure.
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More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will
be published on the MHRA
Products website within 7 days of approval.
-
For more information about small cell lung cancer, visit:
https://www.nhs.uk/conditions/lung-cancer/
