European Medicines Agency Recommends Granting a Marketing Authorisation for Pemetrexed Accord and Pemetrexed Actavis

These medicinal products are intended for unresectable malignant pleural mesothelioma and locally advanced or metastatic NSCLC other than predominantly squamous cell histology

On 19 November 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal products Pemetrexed Accord and Pemetrexed Actavis, 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.

Pemetrexed Accord

The applicant for Pemetrexed Accord is Accord Healthcare Ltd.

Pemetrexed Accord will be available as a powder (100 mg, 500 mg and 1,000 mg) for concentrate for solution for infusion. The active substance of Pemetrexed Accord, 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 Accord is a generic of Alimta, which has been authorised in the EU since 20 September 2004.

Studies have demonstrated the satisfactory quality of Pemetrexed Accord. Since Pemetrexed Accord 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 Accord in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer

Pemetrexed Accord in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Pemetrexed Accord is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Pemetrexed Accord is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology."

It is proposed that Pemetrexed Accord 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 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.

Pemetrexed Actavis

The applicant for Pemetrexed Actavis is Actavis Group PTC ehf.

Pemetrexed Actavis will be available as a concentrate (100 mg, 500 mg and 1,000 mg) for solution for infusion. The active substance of Pemetrexed Actavis, 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 Actavis is a hybrid of Alimta, which has been authorised in the EU since 20 September 2004.

Studies have demonstrated the satisfactory quality of Pemetrexed Actavis. Since Pemetrexed Actavis 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 in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer

Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology."

It is proposed that Pemetrexed Actavis 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 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.