This is a selection from all paediatric investigation plans in the therapeutic area of oncology, such as listed in this webapp or made public by the EMA. Melanoma is malignant neoplasm that is rare in adults and during childhood . The development of anti-cancer medicines for adults with malignant melanoma triggered the need to discuss a paediatric development, which for some medicines was limited to melanoma and for others went to include also other malignant tumours, likely in view of the medicine's pharmacological action. Some of the medicines listed below are listed as "voluntary" PIPs in . Eventually, this development model may lead to new medicines for paediatric-specific cancers.
OverviewThe table includes paediatric investigation plans that refer to melanoma or solid malignant tumours and where melanoma was the first authorised indication. Information on trial start was taken from ClinicalTrials.Gov. The date of submission of marketing authorisation was taken from the European Public Assessment Report (EPAR). Last update: 2018-04-25.
|Active substance||Children with a melanoma investigated||Children with a solid malignant tumour in early trial||Early trial with children started||Melanoma marketing authorisation in adults submitted on||Marketing authorisation in children on (indication)|
|selumetinib||Extrapolation, subsequently waived||No||2011-05-11 (plexiform neurofibroma)||None known so far|
|dabrafenib||Inclusion possible in solid malignant tumour trial||Yes||2012-09 (melanoma), 2013-02-27 (brain tumours), 2015-01-15 (V600 mutant cancers)||2012-07-24|
|vemurafenib||Yes, subsequently waived||No||2013-01||2011-05-04|
|ipilimumab||Yes||Yes||2007-10-01 (solid tumours, lymphoma), 2012-02-17 (melanoma)||2010-05-05||Yes (melanoma, 2018-01-18)|
|binimetinib||Yes||Yes (not in PIP)||2016-04 (ras/raf activated solid malignant tumours)||None known so far|
|encorafenib||Yes||None found so far||None found so far||None known so far|
|trametinib||Inclusion possible in solid malignant tumour trial||Yes||2015-01-15||2013-02-07|
|nivolumab||Inclusion possible in solid malignant tumour trial||Yes||2015-02-02||2014-09-02|
|pembrolizumab||Inclusion possible in solid malignant tumour trial||Yes||2015-03-18||2014-06-04|
|talimogene laherparepvec||Inclusion possible in solid malignant tumour trial||Yes (non CNS)||2017-08-16||2014-08-28|