29 March 2017 EMA/668812/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 20-23 March 2017

During its March 2017 meeting, the CHMP reviewed 4 recommendations for eligibility to PRIME: 4 were denied. The individual outcomes adopted this month are listed below.

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Eligibility denied Substance type

Immunological

Therapeutic area

Oncology

Therapeutic indication

Treatment of metastatic breast cancer

Type of data

Type of

supporting request

applicant

Nonclinical

SME

+ Clinical exploratory Chemical Chemical

Oncology Oncology

Treatment of locally advanced or metastatic HER2+ breast

Nonclinical

carcinoma

+ Clinical exploratory

Treatment of Ovarian Cancer

Nonclinical

SME Other

+ Clinical exploratory Advanced Therapy

Haematology haemostaseology

Treatment of Fanconi anaemia type A

Nonclinical

Other

+ Clinical exploratory

SME applicants are micro-, small-and medium-sized-enterprises registered with the Agency’s SME office. Other type of applicants are those not qualifying or not registered as SME or not fulfilling the definition of academic sponsors.

Recommendations on eligibility to PRIME scheme EMA/668812/2016

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 23 March 2017 By therapeutic area

By type of applicant

* One eligible product has subsequently been withdrawn from the scheme at the applicant’s request

Out of scope indicates eligibility requests received but not started by EMA as they were deemed outside the scope of the scheme or with a format and content inadequate to support their review. These are not included in the breakdown by type of applicant or by therapeutic area. Recommendations on eligibility to PRIME scheme EMA/668812/2016

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Recommendations on eligibility to PRIME scheme - European ...

Mar 29, 2017 - SME. Chemical. Oncology. Treatment of locally advanced or ... the scope of the scheme or with a format and content inadequate to support.

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