Oncology and Haematology
Oncology isn’t just an area of expertise for us, it is our area of interest, which makes us an expert and enthusiastic partner to help you bring oncological and haematological medicines to market.
Over the past two decades, cancer research has transformed. Advances in technology and tumour biology have revolutionised cancer medicine, paving the way for more precise therapies and a deeper understanding of the complex ecosystems surrounding cancerous tumours.
There has been a marked shift in the way we view cancer as a disease and how cancer develops. Whereas twenty years ago, the narrative focused on the malignant cells themselves, now we understand that how immune cells function—or fail to function in the case of cancer—is a fundamentally important narrative shift that has opened the door for precision medicines including immunotherapies, vascular-normalizing drugs, immune-checkpoint inhibitors (ICIs), tyrosine kinase inhibitors (TKIs) and chimeric antigen receptor (CAR)-T cell therapies.
A change in perspective for oncology
The tumour microenvironment (TME) and the immune system have become focal points in cancer research. Previously, cancer research focused on the malignant cells themselves. However, new biomarker-led medicinal products have emerged from research conducted on the immune system, particularly how malignant cells target compromised immune systems and failed immunosurveillance.
This has led to advancements in research on biomarkers as a tool to search for immunogenicity and immunophenotyping of antibodies to refine the morphologic diagnosis of cancers. The shift in focus to the tumour microenvironment (TME) has also paved the way for more sophisticated immunotherapies to play a pivotal role in cancer management and treatment.
Targeted small molecules, biologics and cell or gene therapies are revolutionising the treatment of solid and haematologic tumours. This revolution in cancer treatment is turning once imminently life-threatening advanced cancers into increasingly chronic conditions, bringing new hope to patients.
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Oncology from a regulatory perspective
Of the 46 positive opinions for new active substances granted by the Committee for Medicinal Products for Human Use in 2024, 15 (~30%) of those were for new cancer medicines.
However, regulatory challenges appear in bringing new cancer medicines to patients, particularly with the transforming treatment landscape, as the treatment landscape segments and new medicines target progressively less common subsets of patients.
Biomarker-driven oncology therapeutics and whole genome cancer sequencing
Read our executive summary.
Subscribe to our Monthly Regulatory Intelligence Scan
Our monthly newsletter gives you the latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy here.
Case Study
Tyrosine kinase inhibitor – solid tumour oncology
Challenge
A pharmaceutical company planned to submit a marketing authorisation application in Europe for a tyrosine kinase inhibitor.
Solution
We wrote a detailed regulatory strategy to gain approval using Phase 2 data. We supported the planning and messaging within the common technical document as part of the global filing team. We also wrote the initial submission of the paediatric investigation plan and successfully applied for an orphan designation.
Result
Planning for the orphan strategy in the context of a non-orphan and orphan indication was pivotal to the regulatory strategy and marketing authorization was granted.