On 24 September 2015, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal products, generics of pemetrexed, Ciambra, Pemetrexed Hospira, and Pemetrexed medac intended for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
The applicant for Ciambra is Menarini International Operations Luxembourg S.A.
The applicant for Pemetrexed Hospira is Hospira UK Limited.
The applicant for Pemetrexed medac is medac Gesellschaft für klinische Spezialpräparate mbH.
Ciambra will be available as 100 mg and 500 mg powder for concentrate for solution for infusion.
Pemetrexed Hospira will be available as 100 mg, 500 mg and 1,000 mg powder for concentrate for solution for infusion.
Pemetrexed medac will be available as 100 mg, 500 mg and 1,000 mg powder for concentrate for solution for infusion.
The active substance of Ciambra, Pemetrexed Hospira, and Pemetrexed medac, pemetrexed, is a multi-targeted anti-cancer antifolate agent (ATC code: L01BA04) that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Ciambra, Pemetrexed Hospira, and Pemetrexed medac are generic of Alimta, which has been authorised in the EU since 20 September 2004.
Studies have demonstrated the satisfactory quality of Ciambra, Pemetrexed Hospira, and Pemetrexed medac. Since Ciambra, Pemetrexed Hospira, and Pemetrexed medac are administered intravenously and are 100% bioavailable, bioequivalence studies versus the reference product Alimta were not required.
The full indication is:
Malignant pleural mesothelioma
Ciambra, Pemetrexed Hospira, and Pemetrexed medac in combination with cisplatin are indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Ciambra, Pemetrexed Hospira, and Pemetrexed medac in combination with cisplatin are indicated for the first line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology.
Ciambra, Pemetrexed Hospira, and Pemetrexed medac are indicated as monotherapy for the maintenance treatment of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
Ciambra, Pemetrexed Hospira, and Pemetrexed medac are indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology.
It is proposed that Ciambra, Pemetrexed Hospira, and Pemetrexed medac be subject to prescription and administered under the supervision of physicians experienced in the use of anti-cancer chemotherapy.
Detailed recommendations for the use of these products will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.