HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA finalizes guidance for opioid use disorder drug R&D; FDA releases draft guidance for PK models, cancer drugs.
One of the highlights of the first presidential program at this year’s European Society for Medical Oncology 2020 Virtual Congress were results from the Checkmate 9ER study by Toni Choueiri, who is the director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute. Checkmate 9ER tested the use of a combination of checkpoint blocker Opdivo (nivolumab, Bristol Myers Squibb Co.) and receptor tyrosine kinase inhibitor Cabometyx (cabozantinib, Exelixis Inc.) as first-line treatment for advanced renal cell carcinoma.
Liquid biopsy startup Elypta AB has raised €6.1 million (US$6.72 million) in a late seed financing led by Industrifonden and Sciety. Norrsken Foundation’s newly launched €100 million “impact-first” fund also contributed to the round. The Stockholm-based company plans to use the money to complete development of laboratory kits and software for measurement and analysis of a panel of metabolites it has identified.
Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said.
Aveo Oncology Inc. is moving closer to a potential NDA filing for its renal cell carcinoma (RCC) drug, tivozanib, following a recently conducted analysis of the ongoing phase III trial Tivo-3. Updated results evidenced "durable improvements" for study participants, all of whom have refractory metastatic RCC, said primary investigator Brian Rini. Company shares (NASDAQ:AVEO) climbed 30.9% to 92 cents Tuesday as Aveo said it would discuss the data with the FDA, which rejected the company's first attempt at approval in RCC in the summer of 2013.
