Cabometyx scores Japanese approval for unresectable hepatocellular carcinoma patients following systemic therapy
pharmafile | November 30, 2020 | News story | Sales and Marketing | Cabometyx, Japan, Takeda
The Japanese Ministry of Health, Labor and Welfare has awarded approval to Takeda for Cabometyx (cabozantinib) as a treatment for unresectable hepatocellular carcinoma (HCC) in patients whose disease has progressed despite prior systemic therapy.
Data from two clinical trials investigating the drug – one a Phase 3 and the other a Phase 2 – in this patient population were used to secure approval. Data from the Phase 3 study had already won marketing authorisation for the drug in the US and the EU in HCC patients who have previously received sorafenib.
“Hepatocellular carcinoma causes approximately 30,000 deaths in Japan each year and is a leading cause of cancer-related death worldwide,” commented Michael M Morrissey, President and Chief Executive Officer of Exelixis. “The approval of Cabometyx in Japan is an exciting next step toward bringing this treatment to liver cancer patients who otherwise have limited treatment options following prior systemic therapy. We’re proud to collaborate with Takeda as we work to bring this treatment to patients in Japan.”
Takeda is pursuing commercialisation of the drug in Japan in partnership with Exelixis, from whom the company bought the exclusive right to market Cabometyx in the country in 2017.
The approval triggers a milestone payment from Takeda to Exelixis of $15 million, as per their existing agreement, upon the first commercial sale of Cabometyx in the country for this indication – something that is expected before the year is out.
Matt Fellows
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