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Drug for metastatic cervical cancer approved by the European Commission

The treatment was able to reduce the risk of death by 31 per cent compared to chemotherapy during study

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A drug that demonstrated significant survival benefit in patients with recurrent or metastatic cervical cancer has been approved by the European Commission. 

Regeneron Pharmaceuticals has announced that the European Commission (EC) approved Libtayo (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

The EC approval in advanced cervical cancer is based on data from the global phase 3 trial, which was conducted with the GOG Foundation, the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan.

The trial evaluated Libtayo in comparison to an investigator’s choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology.

In March 2021, the trial was stopped early based on the highly significant effect of Libtayo on overall survival (OS) among squamous cell carcinoma (SCC) patients following a unanimous recommendation by the Independent Data Monitoring Committee.

“Despite recent advancements in the prevention and treatment of cervical cancer, there remain limited options for people with recurrent or metastatic cases,” said Israel Lowy, senior vice president at Regeneron.

“Libtayo was the first PD-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a Phase 3 trial.

“With this fourth approval from the European Commission, Libtayo can now be extended to appropriate patients in the European Union with advanced cervical cancer, irrespective of their PD-L1 status or histology.”

Professor Ignace Vergote, investigator and gynaecologist oncologist at University Hospitals Leuven in Belgium, and vice-chair of the Trial Steering Committee, said: “Consistent with our mission to bring the best treatments to patients across Europe living with gynaecological cancers, we are proud to have been a part of this landmark trial for Libtayo.

“Libtayo is an important advancement for patients with recurrent or metastatic cervical cancer whose disease has progressed following platinum-based chemotherapy and could offer a new standard of care in this setting.

“We are grateful to those who participated in the trial and to our partners at Regeneron, ENGOT, the GOG Foundation and NRG Oncology-Japan without whom this approval would not have been possible.”

Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44.

Approximately 600,000 new cases of cervical cancer and 350,000 deaths from cervical cancer occur worldwide each year.

Almost all cases are caused by human papillomavirus (HPV) infection, with approximately 80 per cent classified as squamous cell carcinoma – arising from cells lining the external portion of the cervix – and the remainder largely adenocarcinomas – arising from glandular cells lining the internal portion of the cervix.

Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.

In addition, Libtayo has also been approved in the EU for the treatment of three other types of cancer, including certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).

 

Adolescent health

WUKA and Royal Yachting Association partner to support women and girls in sailing

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WUKA has announced a groundbreaking partnership with the Royal Yachting Association (RYA), including RYA Scotland and RYA Northern Ireland, supporting women and girls in sailing.

Building on WUKA’s growing #TackleAnything campaign – which has already reached thousands of girls across sports in the UK – this collaboration brings practical period solutions into sailing.

Together, WUKA and the RYA are committed to breaking down barriers so periods never limit confidence, participation, or performance on the water.

Ruby Raut, WUKA founder & CEO, said: “Partnering with the RYA has been incredibly important for us at WUKA.

“Sailing is an amazing way for women and girls to build confidence, and periods shouldn’t hold anyone back from enjoying the water or reaching their full potential.

“Through this partnership and our #TackleAnything campaign, we’re proud to provide practical solutions and innovative products that help female sailors feel comfortable, confident, and free to focus on learning, performing, and having fun.

“Breaking down barriers and supporting women to tackle anything — on land, at sea, and everywhere in between – has never felt more meaningful.”

WUKA, which stands for Wake-Up Kick Ass, shares the RYA’s commitment to inclusivity and empowerment.

In 2023, WUKA launched #TackleAnything, a campaign supporting women, girls and sportspeople with periods. Since its launch, the initiative has reached 3,576 girls across 46 clubs and partnered with a range of sports across the UK – from Scottish Gymnastics to Titans wheelchair basketball – helping young athletes play without limits and stay confident, comfortable, and in the game.

The brand offers period-friendly aquatic apparel and practical solutions that help women train and compete with freedom of movement and total assurance.

Through this partnership, WUKA will provide innovative period swimwear for young sailors across key RYA programmes, including the NI Sailing Team, the RYA Scotland Performance Pathway Programme, and the British Sailing Pathways Talent Academies.

By combining WUKA’s mission to challenge stigma with the RYA’s commitment to inclusion, the partnership ensures young sailors can focus on what matters most – learning, performing, and enjoying their time on the water – with confidence and comfort. RYA members will also receive a 10 per cent discount on WUKA products.

Sailing offers incredible benefits for women and girls, but time on the water can present unique challenges -particularly during menstruation.

Together, WUKA and the RYA are providing practical solutions that remove these barriers, helping young sailors participate fully and confidently in the sport.

Sara Sutcliffe, RYA CEO, said: “At the RYA, we have been making strides to break down barriers for women of all ages to help ensure they can experience the water in a supportive and positive environment.

“From education workshops and practical sessions, we want to make sure our female sailors are empowered and this partnership is another great example of how we can demonstrate possible tools to equip them to succeed”.

This partnership is part of the RYA’s wider commitment to making sailing a sport where women and girls can thrive. Alongside initiatives such as the Female Futures Group, the Women’s Race Officials Programme and all new Talent Academy Female Future’s Camps; it demonstrates a continued focus on removing barriers and creating meaningful opportunities across every stage of the sailing.

WUKA’s involvement ensures that practical solutions are available on the water, from innovative period swimwear to support resources, helping young sailors feel fully equipped and confident during training and competition.

By integrating these tools into RYA programmes, WUKA brings a new level of comfort and assurance to female athletes, allowing them to focus entirely on performance, enjoyment, and growth in the sport.

For any women and girls looking to learn more about sailing, visit www.rya.org.uk.

For more information on WUKA visit www.wuka.co.uk.

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Study links changing population to low London screening rates

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London’s shifting population is holding down breast screening uptake, experts have said, with the capital at 62.8 per cent in 2024, below the NHS’s acceptable 70 per cent threshold.

The London Assembly Health Committee recently heard that the capital faces distinct challenges compared with the rest of the country and that these issues must be addressed.

Josephine Ruwende, a cancer screening lead at NHS England, said frequent moves within the rented sector and the cost-of-living crisis pushing people out of London had made it difficult to reach eligible patients, which she described as “population churn”.

She said: “This is people changing addresses and then not updating their GP, this then affects the invitation process because GP details are used to identify individuals who are eligible.

“In boroughs where we have the highest population churn, we see it strongly associated with lower uptake.”

She noted that even in the wealthiest boroughs there can be high levels of movement, with around 40 per cent of residents changing address within a year.

Such areas also tend to have more people who own second homes or spend long periods abroad, making it harder for the NHS to keep contact details up to date.

As a result, screening invitations may be sent to out-of-date addresses or to people who are overseas.

Leeane Graham, advocacy lead at Black Women Rising, which supports women of colour with a cancer diagnosis, said there were cultural barriers, fear and a mistrust of the health service due to previous experience within communities.

She said: “If you’ve never been for a breast screening before, the thought of having a mammogram can be really, really terrifying.”

Helen Dickens, from Breast Cancer Now, said other reasons included a lack of understanding of breast screening, along with concerns about discomfort, trust and practical issues such as travel.

She said: “We have amazing public transport and we feel that we’ve got great accessibility, but we also know that we don’t have screening centres in every borough.

“We know that for some women that barrier of transport and access will still be a really big reason why they’re not attending screenings.”

NHS London launched its first screening campaign last year in response to the figures, aiming to increase detection at an earlier stage.

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Features

The hidden cost of “business as usual” in gynecologic surgery

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A Common Surgery with Outsized Consequences

Hysterectomy and myomectomy are among the most frequently performed surgeries worldwide.

Minimally invasive and robotic approaches have delivered clear benefits at the point of care, including shorter hospital stays, faster recovery, and fewer complications.

To remove the uterus or fibroids through small incisions, surgeons use a technique known as morcellation, in which tissue is cut into smaller pieces for extraction during surgery.

However, when tissue is cut without containment, those short-term gains can be offset by downstream harm.

The risks fall into three interconnected categories:

  • dissemination of undiagnosed malignancy
  • spread of benign tissue, including endometriosis and parasitic fibroids
  • legal and financial exposure linked to off-label device use

Crucially, these costs often surface years after the original procedure and rarely where the original cost savings were realized.

Cancer Dissemination: A Known and Preventable Risk

The risk of occult uterine malignancy in women undergoing surgery for presumed benign fibroids is well documented.

The U.S. Food and Drug Administration has estimated this risk at approximately 1 in 350 women, prompting repeated safety communications recommending tissue containment during morcellation.

When morcellation is performed without containment, undiagnosed cancer will be dispersed throughout the abdominal cavity, effectively upstaging disease from localised to disseminated.

The clinical implications are profound, and so are the economic consequences.

Treatment costs for early-stage uterine cancer typically range from $40,000 to $60,000. Once disease becomes disseminated, costs can exceed $150,000 to $300,000, excluding indirect costs such as lost productivity, long-term disability, and caregiver burden.

Beyond treatment expenses, litigation related to morcellation-associated cancer spread has resulted in multi-million-dollar settlements, particularly during the power morcellation litigation wave of the mid-2010s. Several cases explicitly tied disease progression to tissue dissemination during surgery.

From a system perspective, a single preventable dissemination event can negate the cost savings of hundreds of minimally invasive procedures.

Benign Tissue Seeding: The Long Tail of Surgical Cost

Cancer is not the only concern.

Uncontained morcellation has also been associated with the spread of benign tissue, including parasitic fibroids and iatrogenic endometriosis, conditions that may present years after the index surgery.

Endometriosis alone represents one of the most expensive chronic gynecologic conditions. Multiple health economic studies estimate annual per-patient costs of $12,000 to $16,000, with lifetime costs exceeding $100,000, driven by repeat surgeries, chronic pain management, hormonal therapy, and fertility interventions.

While the financial impact may surface years later, downstream harm is increasingly traced back to the index procedure, including the choice between FDA-cleared containment and off-label alternatives used during tissue extraction.

Off-Label Use and the Quiet Accumulation of Liability

One of the least visible, but most consequential, dimensions of morcellation risk lies in off-label device use.

Many tissue bags currently used during morcellation are not FDA-cleared for prevention of tissue spillage during organ cutting and removal. While off-label use is common in medicine, it carries distinct legal and financial implications when complications occur.

Risk management guidance from MedPro Group, one of the largest medical malpractice insurers in the United States, has repeatedly warned that off-label use increases professional liability exposure in three key ways:

1. Burden of justification

When an FDA-cleared alternative exists, the legal burden shifts to the surgeon to prove that off-label use met the standard of care.

2. Informed consent vulnerability

Standard consent language may be insufficient for off-label device use, increasing exposure to failure-to-warn claims if complications arise.

3. Changed liability dynamics

Off-label use alters traditional liability dynamics, increasing scrutiny on clinical decision-making at the hospital and surgeon level.

Legal scholarship published in Clinical Orthopaedics and Related Research has echoed these concerns, noting that courts increasingly allow off-label status to be considered in malpractice cases, particularly when patient harm occurs and safer alternatives were available.

Recent U.S. court decisions have further reinforced that while off-label use is generally permitted, it is not immune from civil liability and, in rare but serious circumstances, criminal consequences when tied to demonstrable patient harm.

FDA Guidance Exists, Adoption Lags Behind

Regulatory expectations around morcellation are no longer ambiguous. The FDA has consistently called for tissue containment during tissue cutting to mitigate the risks of cancer and tissue dissemination.

Yet real-world adoption remains inconsistent.

A 2025 survey reported by News-Medical found widespread gaps in safe tissue containment during laparoscopic gynecologic surgery.

Respondents cited variability in training, institutional protocols, and access to FDA-cleared containment systems. Many surgeons reported reliance on improvised or non-cleared solutions despite growing awareness of regulatory and legal risk.

The result is a widening gap between guidance and practice, one that is increasingly visible to regulators, insurers, and hospital leadership.

Who Ultimately Pays?

The economic impact of uncontained morcellation does not fall on a single stakeholder.

  • Hospitals face litigation exposure, rising malpractice premiums, re-operations, and reputational risk.
  • Surgeons shoulder personal liability, heightened scrutiny around informed consent, and evolving standards of care.
  • Payers absorb downstream oncology costs, chronic disease management, and repeat interventions.
  • Patients bear the heaviest burden, including preventable morbidity, fertility loss, financial toxicity, and erosion of trust.

Taken together, these costs far exceed the price of prevention.

From Clinical Risk to Market Response

This growing recognition of risk has begun to reshape the market.

Before regulatory scrutiny intensified, power morcellation was widely adopted because it saved time, reduced operating room burden, and supported high procedural throughput.

It represented a multi-billion-dollar global market, supported by major surgical device manufacturers and deeply embedded in minimally invasive gynecologic practice.

The withdrawal of power morcellation from many hospitals did not eliminate the clinical need for efficient tissue extraction. Instead, it created a prolonged gap between surgical efficiency and acceptable risk.

That gap is now beginning to close.

With the emergence of FDA-cleared tissue containment systems designed specifically for morcellation, hospitals are reassessing whether power morcellation can be responsibly reintroduced in a manner aligned with regulatory guidance, patient safety, and liability mitigation.

This has significant implications for operating room efficiency, surgeon ergonomics, and system-wide cost management.

One example is Ark Surgical, a U.S.-focused surgical technology company advancing safety-first approaches to tissue extraction.

Its double-wall, airbag-like LapBox containment chamber was developed to support FDA-aligned morcellation while integrating into existing laparoscopic workflows, an increasingly important consideration as hospitals evaluate not just procedural efficiency, but long-term risk exposure.

Ark Surgical is currently in an active investment round, reflecting broader investor interest in technologies that address regulatory-driven risk while unlocking previously constrained markets.

More broadly, capital is flowing toward solutions that make it possible to restore clinical efficiency without reintroducing legacy risk.

The Cost Question Is No Longer “If,” but “When”

Healthcare systems already absorb the cost of uncontained morcellation through litigation, chronic disease management, repeat interventions, and loss of trust.

What has changed is visibility.

As clinical data, regulatory expectations, and market solutions converge, the question is no longer whether containment matters, but whether healthcare systems can afford to continue treating it as optional.

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