NICE Reverses Decision, Approves Genmab's Tivdak for NHS Use in Cervical Cancer
Key Insights
NICE has reversed its initial rejection and now recommends Genmab's Tivdak (tisotumab vedotin) for NHS use in recurrent or metastatic cervical cancer (search) patients.
The approval follows improvements to Genmab's economic model incorporating real-world evidence from five-year patient follow-up data and updated cost comparisons.
Tivdak demonstrated a 30% reduction in death risk with median overall survival of 11.5 months versus 9.5 months for chemotherapy (search) in the innovaTV 301 trial.
The UK's National Institute for Health and Care Excellence (NICE) has reversed its initial rejection of Genmab's cervical cancer (search) therapy Tivdak, now recommending the treatment for NHS use after the Danish company addressed economic concerns through an improved cost-effectiveness model.
In final draft guidance released two months after its initial rejection, NICE backed the commissioning of Tivdak (tisotumab vedotin) as a monotherapy for adults with recurrent or metastatic cervical cancer (search) whose disease has progressed despite earlier systemic therapy. The tissue factor (search)-targeting antibody-drug conjugate was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in December as an alternative to chemotherapy (search).
Clinical Evidence Supports Approval
The approval draws on findings from the phase 2 innovaTV 301 study, which demonstrated median overall survival of 11.5 months with Tivdak compared with 9.5 months in a chemotherapy (search) control arm, equivalent to an approximately 30% reduction in the risk for death. The confirmed objective response rate was also significantly higher with Tivdak at 17.8% compared to 5.2% for chemotherapy.
"Despite real progress in prevention and early detection, women with metastatic or recurrent cervical cancer (search) still face poor outcomes and limited options beyond chemotherapy (search)," said Prof Susana Banerjee of The Royal Marsden NHS Foundation Trust, who served as the UK lead for innovaTV 301. She noted that Tivdak "may offer clinically meaningful improvement in survival outcomes for some patients in this hard-to-treat setting."
Economic Model Refinements Enable Access
NICE's initial concerns centered on the economic model proposed by Genmab, with the reimbursement authority stating it was unable to determine whether the therapy would represent a cost-effective use of NHS resources. The list price had not been approved at the time, and cost-effectiveness estimates were considered "higher than the range normally considered acceptable."
The reversal came after Genmab made changes to its economic model, incorporating real-world evidence collected from patients followed for five years and updated cost data for alternative therapies. The Cancer Drugs Fund will provide initial coverage of Tivdak ahead of routine NHS commissioning.
Addressing Unmet Medical Need
Cervical cancer (search) affects approximately 3,300 women diagnosed in the UK annually, with around 900 deaths from the disease each year. Among patients who respond to initial treatment, recurrence occurs in up to 30% of cases. According to NICE, Genmab estimates the eligible patient population in England at around 117 people, assuming ultimate approval for use.
While national disease prevention and early detection efforts continue to advance, patients with advanced cervical cancer (search) face limited treatment options, with the disease remaining the fourth leading cause of cancer-related death among women worldwide.
Commercial Significance for Genmab
Tivdak represents a strategically important product for Genmab as the first therapy launched independently of commercial partners, establishing the foundation for future self-marketed medicines. While partnered with Pfizer in the US, where it launched in 2021, and with Zai Lab in China, Genmab leads commercial efforts in Europe and other markets including Japan.
The company reported $39 million in Tivdak revenues during the first quarter, ahead of a broad European rollout. Genmab has been expanding its commercial infrastructure to support this launch, establishing new offices in the UK, France, and Germany. Analysts have previously suggested the therapy could achieve peak global sales of $600 million.
Matt Kiely, Genmab's UK general manager, expressed commitment to "working with the NHS, clinicians, and patient groups to support timely access and smooth implementation" following the positive NICE decision.