Drugs

Tango Therapeutics Encouraging Cancer Drug Data

Tango Therapeutics says new data from its ongoing Phase 1-2 study of vopimetostat (TNG462) showed early signs of efficacy across multiple methylthioadenosine phosphorylase (MTAP)-deleted cancers, including pancreatic and lung tumors, paving the way for a pivotal trial next year. Such cancers are described as malignancies characterized by the loss of the MTAP gene, a common genomic alteration that creates a specific metabolic vulnerability in cancer cells, which can be exploited for targeted therapy.

The investigational oral PRMT5 inhibitor achieved a 25% objective response rate and a median progression-free survival (mPFS) of 7.2 months in second-line pancreatic cancer patients — more than double that seen in historical control studies, according to the company. Across 16 cancer types, the ORR was 27%, with a disease control rate of 78% and mPFS of 6.4 months.

Following discussions with FDA later this quarter, Tango plans to launch a global, randomized pivotal trial in 2026 enrolling roughly 300 patients with MTAP-deleted pancreatic cancer who have received one prior line of therapy. Patients will be randomized to receive either vopimetostat 250 mg once daily — the FDA-aligned “go-forward” dose — or one of four standard chemotherapy regimens.

Tango notes that vopimetostat is also being evaluated in combination with two Revolution Medicines RAS(ON) inhibitors — daraxonrasib and zoldonrasib — in patients with MTAP-deleted, RAS-mutant pancreatic and lung cancers. The first dose-escalation cohort has been fully enrolled, with early safety data showing the combination to be well-tolerated, it says.

Additionally, the company says the drug has so far demonstrated a manageable safety and tolerability profile at 250 mg once daily, with most treatment-related adverse events being mild (Grade 1). The most common were nausea (26%), anemia (20%), fatigue (19%), dysgeusia (19%), and thrombocytopenia (13%).

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