Drugs

Hutchmed NDA for Colorectal Cancer Drug

Hutchmed Ltd. has completed a rolling NDA submission for fruquintinib, wgich it describes as a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3 for treating refractory metastatic colorectal cancer (CRC). The submission is based on data from the global Phase 3 multi-regional clinical trial FRESCO-2 conducted in the U.S., Europe, Japan and Australia that investigated fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with refractory metastatic CRC.

The study, according to the company, demonstrated that treatment with fruquintinib resulted in a statistically significant increase in the primary overall survival (OS) endpoint and the key secondary progression-free survival (PFS) endpoint compared to placebo. The median OS was 7.4 months for the 461 patients treated with fruquintinib compared to 4.8 months for the 230 patients in the placebo group, it says. The median PFS was 3.7 months for patients treated with fruquintinib compared to 1.8 months for patients on placebo.

Earlier this month, Hutchmed and Takeda Pharmaceutical Co. entered into an exclusive license agreement to further the global development, commercialization and manufacture of fruquintinib outside China. In China, fruquintinib is approved under the brand name Elunate, which is marketed in partnership with Eli Lilly.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome