EMA Recommends Granting a Marketing Authorisation for Pemetrexed Hospira UK Limited

It is intended for treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic NSCLC other than predominantly squamous cell histology

On 23 February 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pemetrexed Hospira UK Limited, intended for 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 this medicinal product is Hospira UK Limited.

Pemetrexed Hospira UK Limited will be available as a powder (100 mg, 500 mg and 1000 mg) for concentrate for solution for infusion. The active substance of Pemetrexed Hospira UK Limited, pemetrexed, is a multi-targeted anti-cancer anti-folate agent (ATC code: L01BA04) that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.

Pemetrexed Hospira UK Limited is a generic of Alimta, which has been authorised in the EU since 20 September 2004. Studies have demonstrated the satisfactory quality of Pemetrexed Hospira UK Limited. Since Pemetrexed Hospira UK Limited is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Alimta was not required.

The full indication is:

Malignant pleural mesothelioma

Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.

NSCLC

Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology.

Pemetrexed Hospira UK Limited is 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.

Pemetrexed Hospira UK Limited is 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 Pemetrexed Hospira UK Limited be administered under the supervision of physicians experienced in the use of anti-cancer chemotherapy.

Detailed recommendations for the use of this product 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.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.