EGFR epidermal growth factor receptor

For cetuximab sarotalocan, brigatinib, lazertinib, afatinib, rociletinib, neratinib, olmutinib, lapatinib, mobocertinib, nimotuzumab, aumolertinib, osimertinib: what EMA and FDA publish about paediatric plans, orphan status and pediatric approvals, and how many registered studies take children. Each line is a yes, no or not published fact from the record linked under it; none of it is a forecast.

• FDA pediatric target list: yes · EGFR is on the list. Membership alone neither requires nor waives a pediatric study.

  Rule: Target is on FDA's Pediatric Molecular Target List (relevant targets). Source: FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01)), 2026-11-11
• EU paediatric investigation plan: yes · EMA/PE/0000236723 (brigatinib, Treatment of anaplastic large cell lymphoma): PM: decision on the application for modification of an agreed PIP, 15 Apr 2025; EMEA-003106-PIP01-21 (aumolertinib, Treatment of lung cancer): W: decision granting a waiver in all age groups for all conditions or indications, 31 Jan 2022; EMEA-001596-PIP02-17-M02 (afatinib, Treatment of all conditions included in the category of malignant neoplasms (excluding central nervous system, haematopoietic and lymphoid tissue neoplasms);Treatment of malignant neoplasms of the central nervous system): PM: decision on the application for modification of an agreed PIP, 13 May 2020; compliance positive 23 Apr 2021; EMEA-002783-PIP01-20 (neratinib, Treatment of breast cancer): W: decision granting a waiver in all age groups for all conditions or indications, 15 Jul 2020; +2 more

  Rule: An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name. Source: EMA data download (dated snapshot), 2026-11-11
• EU orphan designation: yes · EU/3/24/2929 positive 28 Jun 2024: Treatment of complex regional pain syndrome; EU/3/18/2110 positive 14 Dec 2018: Treatment of Fanconi anaemia; EU/3/08/550 positive 3 Jun 2008: Treatment of pancreatic cancer

  Rule: An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status. Source: EMA data download (dated snapshot), 2026-11-11
• Authorised in the EU: yes · Lazcluze: authorised since 20 Jan 2025; Aumseqa: revoked since 12 Feb 2026; Tagrisso: authorised since 1 Feb 2016; Giotrif: authorised since 25 Sept 2013; +5 more

  Rule: An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file. Source: EMA data download (dated snapshot), 2026-11-11
• FDA orphan designation: not published · FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link

  Rule: Would be: an FDA orphan designation names the drug. Source: FDA orphan designations search
• FDA pediatric oncology approval: no · FDA's table lists no pediatric approval of cetuximab sarotalocan, brigatinib, lazertinib, afatinib, rociletinib, neratinib, olmutinib, lapatinib, mobocertinib, nimotuzumab, aumolertinib, osimertinib

  Rule: FDA's Pediatric Oncology Drug Approvals table names the drug. Source: FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03), 2026-11-11
• Registered studies open to children: yes · 31 interventional studies of cetuximab sarotalocan, brigatinib, lazertinib, afatinib, rociletinib, neratinib, olmutinib, lapatinib, mobocertinib, nimotuzumab, aumolertinib, osimertinib include patients under 18; 7 are recruiting, not yet recruiting or active

  Rule: The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age. Source: ClinicalTrials.gov search, 2026-11-11

Rare pediatric disease voucher. FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news. FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs

Each drug, stage and indication links to its Open Targets record, where the trials and approvals behind it are listed. Salt forms (for example a mesylate) are listed as Open Targets records them, as separate entries.