A Pill Is Raising Hope for One of the Deadliest Cancers. How Fast Should Patients Get It?
Daraxonrasib showed tumor shrinkage in 29% of patients and extended median survival to 15.6 months, prompting FDA's new accelerated review under a national priority program.
6 Articles
6 Articles
A pill is raising hope for one of the deadliest cancers. How fast should patients get it?
By Daniel Gilbert The Washington Post At 69 years old, Debby Orcutt was diagnosed last year with pancreatic cancer, a condition so dire that her doctor refused to tell her how long she had to live. With few good options, she enrolled in a clinical trial for an experimental drug. “I just looked at it like, what have I got to lose?” she said. “I’m gonna die.” A scan last week showed her tumor had shrunk 64 percent since starting the drug in Januar…
Backbone Potential: Actuate's Elraglusib Shows Promise vs. Pancreatic Cancer
Five years after Alex Trebek shared publicly his diagnosis of stage IV metastatic pancreatic cancer, therapies for the disease remain few, and limited to specific patient subgroups. Metastatic pancreatic cancer accounts for approximately 80–85% of all pancreatic cancer diagnoses, a treatment market that is projected to grow at a compound annual growth rate of 12.3%, from $2.92 billion last year to $5.84 billion by 2030 (Grand View Research). Eve…
FDA speeds development of oral pancreatic cancer treatment
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to daraxonrasib, an oral therapy being developed by Revolution Medicines to treat pancreatic cancer. The FDA gives this designation to experimental medicines designed to treat conditions affecting fewer than 200,000 people in the U.S. The goal is to provide additional economic incentives to companies investing in treatments for rare conditions, where the small number…
Quanterix VP: Why biomarkers are no longer supplemental
Biomarkers have moved from “nice-to-have” to the backbone of drug development, says Quanterix’s Jorge Marques Signes, who argues they now shape feasibility, timelines and even payer expectations before sponsors commit thousands of patients or years of spend. “Biomarkers are not supplemental anymore,” said Marques Signes, VP of Accelerator & Clinical Services at Quanterix. “They are… The post Quanterix VP: Why biomarkers are no longer supplementa…
In a Potential Mega Deal, Takeda Buys Innovent Cancer Candidates
Takeda announced last week that it would acquire at least two late-stage oncology candidates, IBI363 and IBI34, for $1.2 billion from China’s Innovent Biologics. Takeda will have worldwide commercialization rights outside of Greater China. With milestones, the deal offers an additional up-to-$10.2 billion for Innovent, making it possibly one of the largest biotech partnerships of the year. Both drug candidates are antibody-drug conjugates (ADCs…
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