Shilpa Medicare launches breakthrough therapy lenvatinib mesylate under brand Lenshil in India

Shilpa Medicare shall launch lenvatinib, at a breakthrough price which is over 50% lower than the existing brand available in India. Prior to the launch of Lenshil, the average therapy cost of Originator lenvatinib in India was about Rs.1.90 lacs.

New Delhi: Shilpa Medicare Ltd., a research-led global integrated pharmaceutical company, recently announced that the company has received regulatory approval to market a lenvatinib mesylate a breakthrough therapy for the treatment of patients with differentiated thyroid cancer (DTC) and hepatocellular carcinoma. This marks the approval of first Indian brand of lenvatinib mesylate fully, manufactured in India.

Shilpa received regulatory approval for Lenvatinib 4 mg and 10 mg capsules, after successfully showing bioequivalence to Lenvima, a brand of Lenvatinib mesylate capsules marketed by Eisai.

The approved dosage strengths are up to 24 mg of lenvatinib alone or combined with other drugs according to the condition being treated.

"The company shall launch lenvatinib, at a breakthrough price which is over 50% lower than the existing brand available in India. Prior to the launch of Lenshil, the average therapy cost of Originator lenvatinib in India was about Rs.1.90 lacs," Shilpa Medicare said in a BSE filing.

Shilpa will commercialize the product under the brand name Lenshil to become the first Indian company in the country to bring the cheaper version of this drug to Indian cancer patients.

"Now Indian patients will get access to this breakthrough therapy at an affordable cost and manufactured in India. The presently available brand of lenvatinib mesylate in the market is being imported into India," the company added.

Lenvatinib is an anti-cancer drug for the treatment of certain kinds of cancers including thyroid and hepatocellular, and potentially for other cancers (renal & endometrium) as well. Lenvatinib is a member of the class of quinolones, an oral multikinase inhibitor that inhibits vascular endothelial growth factor (VEGF) receptors (VEGFR 1-3), fibroblast growth factor (FGF) receptors (FGFRl-4), platelet-derived growth factor (PDGF) receptor a, KIT, and RET.

First approved in 2015 by US FDA for thyroid cancer, in 2018 Lenvatinib capsules was approved as a first-line therapeutic option for the treatment of patients with unresectable hepatocellular carcinoma (HCC). It is expected that lenvatinib will be approved for many other cancers in coming years.

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