Very high-alert therapy area: Oncology consistently generates the highest volume of PMCPA cases across all therapy areas. Checkpoint inhibitor comparisons, survival endpoint promotion, congress presentations with unpublished data and patient advocacy funding are among the most frequently investigated issues.
Promoting overall survival data where only progression-free survival has been demonstrated — or implying OS equivalence — is one of the most common grounds for upheld PMCPA complaints in oncology. Endpoint selection must be accurate and transparent.
Materials that effectively promote prescribing based on biomarker status beyond the licensed indication, or that imply a broader patient population than approved, are a persistent high-risk area for oncology teams.
Promotional activity that implicitly or explicitly encourages use of a product in combination regimens not approved in the licence — particularly relevant for CDK4/6 and PARP inhibitors — frequently results in PMCPA complaints.
Funding arrangements with cancer patient advocacy organisations require full transparency and must not create an appearance of promotional intent. Oncology patient advocacy is highly organised and visible to regulators.
Using data presented at oncology congresses (ASCO, ESMO) in promotional materials before full publication, or out of context from poster presentations, is a frequent source of regulatory challenge.
Any promotional dimension to early access programme communications — including MSL involvement, materials and digital content — must be carefully managed to avoid breach of the prohibition on pre-licence promotion.
Built specifically for pharma teams working in oncology — not generic compliance content repurposed for your therapy area.
The pack includes expert walkthroughs of all relevant PMCPA adjudications in the oncology space. Here are three landmark cases.
The pack includes all relevant oncology PMCPA cases with video walkthroughs, expert commentary and quiz questions.
MSLs and medical advisors presenting checkpoint inhibitor and precision oncology data, managing KOL relationships and responding to off-label requests from oncologists
Oncology sales specialists and brand managers responsible for promotional materials across immuno-oncology and targeted therapy portfolios
Clinical teams communicating trial data at congresses, in publications and to investigators — where the boundary with promotion must be carefully managed
Regulatory affairs and compliance officers reviewing oncology promotional materials, early access communications and congress content for ABPI Code compliance
Speak to us about the Oncology Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.
Need more therapy areas? See all 12 therapy area packs →
SGLT-2 inhibitors, PCSK9 inhibitors, sacubitril/valsartan. CVOT data, class effects and HF vs MACE claims.
All 2,000+ PMCPA cases. Video. Podcast. Quiz. 5 points per case. The only case library of its kind in the UK.
12 therapy area packs covering Respiratory, Oncology, Cardiovascular, CNS, Diabetes, Immunology, Infectious Diseases, Dermatology, Musculoskeletal, Ophthalmology and more.
One real case. One key lesson. Every week — free.