03 junio 2008
Yondelis , el Plan - B del Dana Farber Cancer Institute ( EEUU ) para Tratar Pacientes con Sarcoma bajo el amparo de la FDA .
Program helpspatients getdrugs afterclinical trials
When her cancer continued toprogress despite standard and experimentaltherapies, Iris Rogers ofScarsdale, N.Y., came to Dana-Farberseeking further options. A promisingdrug called ET-743 – extracted from amarine creature called the sea squirt –was being tested here. Clinical trialsof the compound were closed, and theU.S. Food and Drug Administration(FDA) had not approved the medicationyet for routine use, but DFCIphysicians had a “plan B” for Rogers.Many patients with advancedcancers or other medical problemscan’t easily get access to unapprovedresearch drugs, even if those very drugsgave hints of benefits in early clinicaltrials. Safety checks and regulatoryhurdles are built into the conventionalthree-phase clinical trial system of theFDA (see sidebar), which is designedto limit the number of people exposedto unproven, potentially toxic drugsbefore they go into widespread clinicaluse and commercial distribution. Still,there are certain carefully definedexceptions permitted by the FDA,and Dana-Farber oncologist SuzanneGeorge, MD, made use of one suchmechanism to put Rogers on ET-743to treat her liposarcoma.
“We’ve enrolled more than 100 patients who are receiving ET-743 under an
expanded access protocol sponsored by the manufacturer, Johnson & Johnson,
and it’s open at multiple sites around the country,” George says.
For more than two years, Rogers and her husband have made the drive from
Scarsdale to Boston every three weeks for infusions of ET-743, which attacks
cancer cells in a novel way and is being tried on other malignancies, including
ovarian cancer. Rogers is thrilled with the results. “I feel fine. I’m exercising,
traveling, and doing a lot of other things,” she says.
When her cancer continued toprogress despite standard and experimentaltherapies, Iris Rogers ofScarsdale, N.Y., came to Dana-Farberseeking further options. A promisingdrug called ET-743 – extracted from amarine creature called the sea squirt –was being tested here. Clinical trialsof the compound were closed, and theU.S. Food and Drug Administration(FDA) had not approved the medicationyet for routine use, but DFCIphysicians had a “plan B” for Rogers.Many patients with advancedcancers or other medical problemscan’t easily get access to unapprovedresearch drugs, even if those very drugsgave hints of benefits in early clinicaltrials. Safety checks and regulatoryhurdles are built into the conventionalthree-phase clinical trial system of theFDA (see sidebar), which is designedto limit the number of people exposedto unproven, potentially toxic drugsbefore they go into widespread clinicaluse and commercial distribution. Still,there are certain carefully definedexceptions permitted by the FDA,and Dana-Farber oncologist SuzanneGeorge, MD, made use of one suchmechanism to put Rogers on ET-743to treat her liposarcoma.
“We’ve enrolled more than 100 patients who are receiving ET-743 under an
expanded access protocol sponsored by the manufacturer, Johnson & Johnson,
and it’s open at multiple sites around the country,” George says.
For more than two years, Rogers and her husband have made the drive from
Scarsdale to Boston every three weeks for infusions of ET-743, which attacks
cancer cells in a novel way and is being tried on other malignancies, including
ovarian cancer. Rogers is thrilled with the results. “I feel fine. I’m exercising,
traveling, and doing a lot of other things,” she says.
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