Sun Pharma cancer drug Pemetrexed Solution for Infusion gets CDSCO panel okay

This came in the wake of the proposal presented by the drug-maker Sun Pharma for manufacturing and marketing of Pemetrexed Solution for Infusion 5 mg/ml, 6 mg/ml, 6.5 mg/ml, 7 mg/ml, 7.5 mg/ml, 8 mg/ml, 8.5mg/ml, 9 mg/ml, 10 mg/ml & 11 mg/ml, 100 ml Ready to Use Infusion Bag requesting local clinical trial waiver.

Pemetrexed is an antifolate containing the pyrrolopyrimidine-based nucleus that exerts its antineoplastic activity by disrupting folate-dependent metabolic processes essential for cell replication. It acts by inhibiting three enzymes used in purine and pyrimidine synthesis—thymidylate synthase(TS) , dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT). Pemetrexed inhibits the synthesis of DNA and RNA, which are essential for the development and survival of both normal and cancer cells, by preventing the production of precursor purine and pyrimidine nucleotides.

The molecular structure of Pemetrexed was discovered by Edward C. Taylor at Princeton University. It was clinically developed by Indianapolis-based drugmaker Eli Lilly and Company in 2004. Pemetrexed is manufactured and marketed by Eli Lilly and Company under the brand name Alimta.

The said drug is used in combination with cisplatin for the treatment of malignant pleural mesothelioma in adults whose disease is unresectable or who otherwise are not candidates for potentially curative surgery. Pemetrexed, in combination with cisplatin, was authorised by the US Food and Drug Administration (FDA) in February 2004 for the treatment of malignant pleural mesothelioma, a kind of tumour of the mesothelium, the thin layer of tissue that surrounds many of the internal organs.

In respect to the above said chemotherapy drug, the committee noted that Pemetrexed in combination with Cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.

Further, Pemetrexed is indicated as a monotherapy for the second-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology.

The committee also noted that Pemetrexed is indicated as a 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.

In addition to this, Pemetrexed in combination with Pembrolizumab and platinum chemotherapy, is indicated for the initial treatment of patients with metastatic non-squamous NSCLC, with no Estimated Glomerular Filtration Rate (eGFR) or ALK genomic tumor aberrations.

At 110th SEC meeting for Oncology & Haematology, held on 13.07.2021 & 14.07.2021, the committee extensively evaluated the proposal presented by the drug-maker Sun Pharma for manufacturing and marketing of Pemetrexed Solution for Infusion 5 mg/ml, 6 mg/ml, 6.5 mg/ml, 7 mg/ml, 7.5 mg/ml, 8 mg/ml, 8.5mg/ml, 9 mg/ml, 10 mg/ml & 11 mg/ml, 100 ml Ready to Use Infusion Bag.

After detailed deliberation the committee recommended for grant of permission for manufacturing and marketing of Pemetrexed Solution for Infusion 5 mg/ml, 6 mg/ml, 6.5 mg/ml, 7 mg/ml, 7.5 mg/ml, 8 mg/ml, 8.5mg/ml, 9 mg/ml, 10 mg/ml & 11 mg/ml, 100 ml Ready to Use Infusion Bag for the following indication

1. Malignant pleural mesothelioma Pemetrexed in combination with Cisplatin, is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.

2. Non-small cell lung cancer (NSCLC)