DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy.
Merck & Co. Inc.'s $1.05 billion acquisition of Peloton Therapeutics Inc. in 2019, a big bet on the hypoxia inducible factor-2 alpha inhibitor belzutifan, has paid off with an earlier-than-anticipated FDA approval of the drug for cancers associated with von Hippel-Lindau disease. The therapy will be marketed as Welireg.
Aveo Oncology Inc. CEO Michael Bailey said the shifting treatment paradigm in renal cell carcinoma (RCC) represents “an advantageous opportunity” for the company with Fotivda (tivozanib), approved March 10 for adults with relapsed or refractory, advanced disease who have received two or more systemic therapies.
Janssen Pharmaceutica NV and Exelixis Inc. are among the many companies releasing new data ahead of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which runs Feb. 11-13.
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
A metastatic renal cell carcinoma (RCC) trial once expected to pave a path to registration for the Calithera Biosciences Inc. candidate telaglenastat failed to show a benefit from the drug in a new analysis of the pivotal phase II study, Cantata. While company executives voiced confidence in the drug's prospects in another indication, non-small-cell lung cancer (NSCLC), analyst and investor faith appeared less sturdy, as company shares (NASDAQ:CALA) fell 44.6% to $2.72 on Jan. 4.
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.
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.