EMA Adopts Positive Opinion for Pemetrexed Baxter

On 13 October 2022, 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 Baxter, intended for the treatment of malignant pleural mesothelioma and non-small cell lung cancer.

The applicant for this medicinal product is Baxter Holding B.V.

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

Pemetrexed Baxter is a generic of Alimta (pemetrexed), which has been authorised in the EU since 20 September 2004. Since Pemetrexed Baxter 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 Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer

  • Pemetrexed Baxter 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 Baxter 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 Baxter 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 Baxter be subject to prescription and administered under the supervision of physicians experienced in the use of anticancer 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.

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