OBJECTIVES

Patients with Non-Small Cell Lung Cancer (NSCLC) report symptoms and poor Health-Related Quality of Life (HRQoL), particularly at advanced stages of the disease. Several instruments are used in clinical trials to record patient experience. This is a review of regulatory labels for NSCLC therapies including symptoms and HRQoL data.

METHODS

A search in Mapi’s PROLABELS database was performed for “Carcinoma, Non-Small-Cell Lung”. Labels from FDA and EMA were included, with no date restrictions. Label text from the corresponding agency website was searched for each identified record. The drug, concept measured, instrument, and endpoint were abstracted and summarized.

RESULTS

The screening process identified 18 labels. Two records were excluded, one mentioning only performance status and one duplicate. Three were from FDA and 13 from EMA, corresponding to 14 drugs, i.e. two drugs had labels in both agencies. EMA included both HRQoL and symptom data for 10 drugs and symptom data only for 3 drugs. All FDA labels included only symptoms. Three lung cancer-specific instruments were identified: EORTC QLQ-LC13, LCSS and FACT-L (used in 6, 5 and 2 labels, respectively). General health status was reported using EORTC QLQ-C30 and EQ-5D-5L (5 and 4 labels, respectively). Four labels did not report the instrument used. Endpoints were time to deterioration in 9 labels, change from baseline in 4 labels, and improvement rate in 3 labels. In general, EMA provides more methodological details.

CONCLUSIONS

NSCLC therapies that succeed in primary endpoints do not always result in Patient Reported Outcomes (PRO) efficacy data to report in the label. Despite there being guidance from both agencies on PROs generally and in oncology, there are few PRO claims included in packaging to date. Our search showed that EMA and FDA have different standards regarding PRO data included in labelling, and the claims are often limited and vague.