MSD has welcomed the National Institute for Health and Care Excellence’s recommendation of pembrolizumab (KEYTRUDA) with chemoradiotherapy as an option for untreated FIGO 2014 stage III–IVA locally advanced cervical cancer (LACC) in adults.

Myomaker Bio, a spin-out from Loughborough University, is scaling its bioengineered human muscle technology to support pharmaceutical and biotech companies seeking faster and more reliable preclinical testing without the need for animal studies.

Its team of scientists and researchers, described as world-leaders in muscle biology, has created human muscle tissues and organs that replicate the structure and function of real skeletal muscle.

The decision marks the first immunotherapy approved for locally advanced cervical cancer in England.

NICE’s recommendation is based on data from the phase 3 KEYNOTE A18 trial, which demonstrated improved progression-free and overall survival compared with standard chemoradiation in patients with locally advanced cervical cancer.
Pembrolizumab is licensed in the UK for use with external beam radiation therapy followed by brachytherapy, for adults who have not received prior definitive therapy.

Louise Broadbelt, a cervical cancer patient, said: “Nothing can prepare you for being diagnosed with cancer. All you want to hear is you will get the best possible treatment and have hope.

“I’m very grateful that I was offered the chance to go on the pembrolizumab clinical trial in 2021 when I was diagnosed with stage III locally advanced cervical cancer whilst under the care of The Royal Marsden Hospital and my wonderful oncologist Dr Susan Lalondrelle. I feel incredibly blessed and lucky that I was offered to participate in the trial and that I am still here today and the results may help others.”

Alexandra Taylor, Consultant in Clinical Oncology at The Royal Marsden, said: “This approval marks an important milestone for women with stage III–IVA locally advanced cervical cancer. It is encouraging that more patients will now have access to a treatment that can genuinely improve their long-term outcomes.”

John McNeill, Oncology Business Unit Director at MSD UK, said: “We welcome today’s recommendation from NICE, which is an important step forward for women living with locally advanced cervical cancer.

“This is a cancer which disproportionately impacts women from underserved backgrounds and where there has long been an unmet need.”

The European Commission has approved Sanofi’s Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) without relapses in the past two years, marking the first EU authorisation for a medicine specifically targeting disability progression in this population.

The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is based on results from the HERCULES phase 3 study in non-relapsing SPMS (nrSPMS), supported by data from the GEMINI 1 and 2 phase 3 studies in relapsing multiple sclerosis.

According to Sanofi, HERCULES showed that Cenrifki significantly delayed the onset of disability progression in nrSPMS.

Sanofi said the safety profile of Cenrifki has been consistent across its clinical programme. The most common adverse events were COVID-19 and upper respiratory tract infections, while significant liver enzyme elevations were also observed.

Drug-induced liver injury is an identified safety risk and the company stressed the importance of strict adherence to liver monitoring requirements.

Cenrifki will be made commercially available in Germany later this year. Sanofi said this will involve close collaboration between local medical teams, MS specialists and patients, supported by a Risk Management Program and a Patient Support Program.

The company described this as reflecting its commitment to a careful approach to introducing a first-in-class medicine for people living with SPMS without relapses.

SPMS is a debilitating stage of MS characterised by continuous accumulation of disability, often without effective treatment options. The condition can lead to fatigue, cognitive impairment, mobility challenges and loss of independence.

Across major European economies, the yearly cost of MS related disability exceeds the average annual income per person, with many patients reducing working hours or leaving the workforce entirely.