A pill is raising hope for one of the deadliest cancers (pancreatic). The question is how fast patients should get it.
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. Im gonna die.
A scan last week showed her tumor had shrunk 64 percent since starting the drug in January, according to her husband. It is the sort of clinical evidence that is stirring optimism and has prompted the Trump administration to put it on a novel path for rapid approval. Orcutt, a grandmother and retired dental assistant, said she wakes up every day at her home near Worcester, Massachusetts, feeling fine. Shes debating her daughter over whether shes well enough to host Thanksgiving.
Based on early clinical trial results, the Food and Drug Administration in October awarded the drugs sponsor, biotech company Revolution Medicines, a new and unconventional accelerated review designed to get promising drugs to patients faster than ever. The pancreatic cancer drug, and other medications selected under the Commissioners National Priority Voucher initiative, will test whether it can expedite novel treatments without compromising the rigor of agency reviews, experts say.
The FDA has said the program can shorten the review of a drug from a year to as little as a month, enabling companies that win the agencys approval to sell a medication sooner.
https://www.yahoo.com/news/articles/pill-raising-hope-one-deadliest-135331927.html