Non-small cell lung cancer is the most common form of lung
cancer, accounting for around 80 to 85 out of 100 cases. It can
be one of three types: squamous cell carcinoma, adenocarcinoma or
large-cell carcinoma.
Sugemalimab is a monoclonal antibody (a type of protein designed
to recognise and attach to a specific target in the body). It
works by attaching to the target called programmed death-ligand 1
(PD-L1). Cancer cells with PD-L1 may switch off some cells of the
immune system. By blocking PD-1, sugemalimab stops the cancer
switching off immune cells and increases the immune system's
ability to kill cancer cells.
Beach, MHRA Interim Executive
Director of Healthcare Quality and Access, said:
Enabling safe access to high quality, safe and effective
medicines is a key priority for us.
We're assured that the appropriate regulatory standards of
safety, quality and effectiveness for the approval of this new
formulation have been met.
As with all products, we will keep its safety under close review.
Sugemalimab is given to the patient in a hospital or clinic under
the supervision of an experienced doctor. The patient's doctor
will give them sugemalimab through an infusion (drip) into a vein
over 60 minutes every 3 weeks.
Clinical trials showed that sugemalimab in combination with
platinum-based chemotherapy was more effective than placebo (a
dummy treatment) in patients with Stage 4 metastatic lung cancer.
The main measure of effectiveness was survival without worsening
(progression) of the cancer. Patients who had sugemalimab
treatment lived on average 9.0 months without the disease getting
worse, compared with 4.9 months for patients who did not receive
sugemalimab.
During clinical studies, common side effects included a decreased
number of red blood cells that carry oxygen around your body,
increased blood levels of liver enzymes, sugar, triglycerides,
and cholesterol, decreased blood levels of calcium, potassium,
sodium and thyroid hormone, increased levels of protein in the
urine, and numbness, tingling or decreased sensation in part of
the body.
As with any medicine, the MHRA will keep the safety and
effectiveness of sugemalimab 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 30 October
2024 to CStone Pharmaceuticals
-
This product was submitted and approved via a National
procedure.
-
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.
