17 April 2018 EMA/242738/2018

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients 5-6 September 2018

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Background and objectives The third multi-stakeholder Paediatric Strategy Forum, jointly organised by EMA and ACCELERATE will focus on checkpoint inhibitors used in combination therapy, in children and adolescents. Paediatric Strategy Forums have been created to facilitate dialogue and provide an opportunity for constructive interactions between relevant stakeholders (patients/patient representatives, clinicians, academics, pharmaceutical companies and regulators) on topics requiring open discussion on development of medicines in the best interests of children and adolescents with cancer. The goal of this meeting is to share information, in a pre-competitive setting, to facilitate the developments of innovative medicines and ultimately their introduction into the standard-of-care of children with malignancies. The first two Paediatric Strategy Forums were held at EMA in January and November 2017 on ALK inhibition and mature B-cell malignancies, respectively. Both can be found in the Paediatric medicines: Workshops page in the European Medicines Agency website. Immune checkpoint inhibitors have shown impressive success in some adult malignancies, in particular, monoclonal antibodies that block the interaction between programmed death ligand 1 (PDL1) on the surface of tumor or antigen-presenting cells, and programmed death 1 (PD-1) on the surface of lymphocytes. Many of these products have now been licensed as first or second line treatments for adult malignancies. Furthermore, the combination of antibodies targeting PD-1 with those targeting the immune checkpoint molecule CTLA-4 has shown particularly high response rates especially in adult patients with metastatic melanoma. Early phase trials in children of single agent checkpoint inhibitors are currently being presented. High response rates are being observed in some cancers common to children and adults, for example in Hodgkin lymphoma. However, these results appear not to be reflected in typical paediatric malignancies. Some combination studies are in progress and others are planned. It therefore seems opportune to review the early results of these early phase trials in children and consider opportunities for paediatric studies in which check-point inhibitors are used in combination including also possible other approaches. This Forum will review the immunological environment of paediatric malignancies, results from the use of checkpoint inhibitors in early phase clinical studies in paediatrics, strategies combining checkpoint inhibitors with other products and alternative immunotherapy strategies. The output will be a published summary from all participants addressing the challenges and documenting the conclusions.

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients EMA/242738/2018

Page 2/4

List of speakers and moderators To be announced

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients EMA/242738/2018

Page 3/4

Draft programme Introduction Immunological environment of paediatric malignancy Development of checkpoint inhibitors in adults with lessons relevant to paediatrics Checkpoint inhibitors in early phase clinical studies Checkpoint inhibitors - Biallelic mismatch repair, MSI status and tumour burden as potential predictive biomarkers Strategies combining checkpoint inhibitors with other products Alternative immunotherapy strategies Strategic discussion Conclusions

Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients EMA/242738/2018

Page 4/4

Paediatric strategy forum for medicinal product development of

Apr 17, 2018 - Paediatric Strategy Forum for Medicinal Product Development of Checkpoint inhibitors for use in combination therapy in paediatric patients. EMA/242738/2018. Page 3/4. List of speakers and moderators. To be announced ...

688KB Sizes 0 Downloads 228 Views

Recommend Documents

Non-animal approaches in support of medicinal product development ...
Oct 5, 2017 - Nature Review drug Discovery 3, 711-715. Hornberg et al 2014. Drug Discovery Today 19; 1131-1136. Most noted safety reasons for withdrawal of marketed drugs: •. Liver toxicity. •. Cardiovascular toxicity. •. CNS effects. Main reas

Non-animal approaches in support of medicinal product development ...
Oct 5, 2017 - Non-animal approaches in support of ... Cardiovascular toxicity >>> CNS, lung, adapative immune system ... for regulatory decision making.

Early dialogue for paediatric development plans - European ...
Apr 25, 2017 - To discuss potential paediatric needs and scope of development for ... Not intended for evaluation of data to support a PIP application.

Guideline on the development of new medicinal products for the ...
Jun 28, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom ...... History of previous use of corticosteroids and 5-ASA is of little ...

Guideline on the development of new medicinal products for the ...
Jun 28, 2018 - ... Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom ..... intestine (e.g. capsule endoscopy) (small intestinal disease only).

Medicinal product with a textile component
Jan 28, 2000 - structed in compact parallel bundles, whereas the meshwork .... spanned by a continuous thread 18 according to FIG. 3,. Which for example ...

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD ...
the field and allow you to write the name you wish to assign to you XEVPRM: 5) Type in the message number you wish to assign to your XEVPRM, then press "Enter" on your keyboard: 6) Expand the tree-view area by clicking on the "+" sign (see screenshot

Post-orphan medicinal product designation procedures: guidance
Jul 12, 2017 - page 6. - Information relating to Brexit under heading 9 added on ..... grounds that the paediatric indication brought a significant clinical benefit in comparison with existing ..... European Union, plus Icelandic and Norwegian.

Volasertib - Notification of discontinuation of a paediatric development ...
Name and signature of the PIP contact point: Signature available on file. Date: 30 Jan 2018. Contact for inquiries from interested parties: Boehringer Ingelheim International GmbH. Telephone: +49 6132 77-8271. Email: paediatrics@boehringer-ingelheim.

Eritoran - Notification of discontinuation of a paediatric development ...
Notification of discontinuation of a paediatric development which is covered by an agreed. PIP Decision. Actives substances(s): eritoran. Invented ... Email: N/A.

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD ...
43 Winston Road. London. E14 5EU. UK. [email protected]. A sponsor organisation with the details: EraLab. Lockington Close. Margate. MA12 4JJ. UK.

eXtended EudraVigilance Medicinal Product Report Message ...
1) Log in to the requested EVWEB environment: EVWEB ...... 4) You can save the XML file of the XEVPRM ACK on your computer by going to "File" and selecting.

eXtended EudraVigilance Medicinal Product Report Message ...
eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step. Guide. EMA/525101/2014. Page 5/83. You are now logged in EVWEB – the organisation ID under which you are logged in is shown in the top right corner: 2) Go to "Create an

Medicinal product with a textile component
Jan 28, 2000 - Foreign Application Priority Data. Feb. 4, 1999. (EP) . ... medical products such as wound compresses consist for example of woven fabric,.

eXtended EudraVigilance Medicinal Product Dictionary - European ...
Apr 5, 2018 - 4) Select the organisation which you wish to update by clicking inside the relevant box; the information for the MAH will be loaded in the tree view. 5) Click on the Organisation information corresponding to "Nobel Company" already load

eXtended EudraVigilance Medicinal Product Report Message ...
Apr 5, 2018 - 1) Log in to the requested EVWEB environment: ...... on your keyboard or double-click with your mouse and the XML of the XEVPRM ACK.

eXtended EudraVigilance Medicinal Product Report Message ...
eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Step-by-Step guide. EMA/543104/2014. Page 3/20. 1.1. Example specifications.

Eritoran - Notification of discontinuation of a paediatric development ...
Notification of discontinuation of a paediatric development which is covered by an agreed. PIP Decision. Actives substances(s): eritoran. Invented name: N/A.

Notification of discontinuation of a paediatric development which is ...
Actives substances(s): vorapaxar sulphate. Invented name: Zontivity. Latest Decision number(s):. 1) P/0131/2016. 2) P/. 3) P/. 4) P/. Corresponding PIP number(s): 1) EMEA-000778-PIP02-12-M01. 2) EMEA- 3) EMEA-. 4) EMEA- ... manufacturing / quality pr

eXtended EudraVigilance Medicinal Product Dictionary - European ...
Apr 5, 2018 - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Step-by-Step Guide. EMA/197297/2018. Page 6/9. 4) Click inside the box of the result (i.e. the AMP that you wish to invalidate); the information for the. AMP will be loaded i

Notification of discontinuation of a paediatric development which is ...
Reasanz. Latest Decision number(s):. 1) P/0292/2016. 2) P/. 3) P/. 4) P/. Corresponding PIP number(s): 1) EMEA-001168-PIP01-11-M03. 2) EMEA- 3) EMEA-. 4) EMEA-. Please note that development of the medicinal product ... manufacturing / quality problem