oncology
Verastem's KRAS inhibitor shows promise in pancreatic cancer
Verastem Oncology is reporting encouraging early results for its KRAS G12D inhibitor, which it’s studying in more than 200 patients with advanced solid tumors like metastatic pancreatic ductal adenocarcinoma and non-small cell lung cancer. The data offer some validation for Verastem’s decision to shift R&D resources toward the drug earlier this year, FierceBiotech notes.
In a phase 1/2 trial, the treatment, VS-7375, produced a 50% response rate among eight patients with metastatic pancreatic cancer receiving it as second-line therapy.
The findings come on the heels of the FDA's August approval of Revolution Medicines' daraxonrasib — the first RAS inhibitor approved for pancreatic cancer. This has intensified interest in drugs targeting KRAS mutations. Verastem plans to launch a Phase 3 trial by year-end and is exploring a potential partnership to help advance the drug.
drug pricing
U.S. delays new rule that could restrict imported meds
The Trump administration is delaying by 90 days a federal rule that could prevent Americans from obtaining prescription drugs from licensed international pharmacies.
The rule, which will require drugs mailed from abroad to go through a customs process that mandates a licensed broker and a financial guarantee in the form of an entry bond, is intended to crack down on the shipment of illegal goods, STAT’s Ed Silverman notes. But in recent weeks, patient advocacy groups and dozens of congressional lawmakers urged the administration to rethink its approach, saying it would have unintended consequences.
“This gives the FDA time to work with CBP to ensure a pathway for patients to continue importing more affordable prescription drugs for personal use when the rule is implement, based on identifiable safety criteria,” said Gabriel Levitt, who heads Prescription Justice, an advocacy group.
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psychedelics
Compass to chart cautious course if it wins approval
Compass Pathways is nearing a potential FDA approval for its psilocybin-based depression treatment, but CEO Kabir Nath says the company has no intention of rushing its rollout. Speaking at the STAT Summit yesterday, Nath touted the potential lasting antidepressant benefits — but said the company’s mindful that negative experiences among patients or providers could set back the entire psychedelics industry.
Steven Hyman, a Harvard University professor and former director of the National Institute of Mental Health, said the field’s credibility would depend on rigorous research, responsible marketing, and long-term safety monitoring.
“I don’t mean this as a pun,” Hyman said. “But being really sober about the way this research is presented — the only way to gain credibility is to be absolutely rigorous.”
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