TORONTO, ON—Bristol-Myers Squibb (BMS) is refusing single patient expanded access of its new immunotherapy drug BMS-936558 to Darcy Doherty, a 48 year old father of three, who has been making impassioned public pleas for it in a desperate attempt to extend his life. In April, Doherty was excluded from the drug’s Phase 1 clinical trial because of new marginal cancer growth in his brain.
“Darcy has led a brave and heroic struggle against this disease for the past five years,” his wife, Rebecca Cumming, explains. “And now, the kids and I are devastated that a promising drug is out there and proving successful in patients with Darcy’s diagnosis, yet we can’t get to it.” The company has repeatedly blocked the family’s appeals for access over the past weeks explaining that it does not have a compassionate use program.
Though at this past weekend’s American Society of Clinical Oncology annual meeting in Chicago, the company touted the drug’s early success. Research presented at the conference show that the drug shrank tumors in 28% of patients with metastatic melanoma, like Doherty, who received it. “Immuno-oncology is a prioritized area of research and development [for us] and we plan to initiate registrational studies for [BMS-036558] in early 2013 for metastatic melanoma,” says Brian Daniels, senior vice-president, Global Development and Medical Affairs at BMS.
Sadly, Doherty does not have months. “I respect the company’s trial criteria,” Cumming adds, “but Darcy cannot live to 2013 without new treatment. We cannot accept that we are not able to get compassionate access to this potentially life-saving drug. We’ve all come so far and worked too hard to be prevented from this drug.”
“We are not in a position to allow [a drug’s] use outside of a highly controlled trial,” states Dr. Michael Giordano, Head of Development, Oncology and Immunosciences at Bristol-Myers Squibb. “We strive to develop promising drugs as quickly as feasible while remaining mindful of protecting patient safety [but the drug] currently does not have an established benefit/risk profile, given [its] limited experience in humans.”
Doherty’s oncologist, Dr. Keith Flaherty, Director of Developmental Therapeutics, Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School, believes that his patient can benefit from this new treatment. “Mr. Doherty had a fantastic response to the then-experimental immunotherapy drug, ipilimumab (Yervoy®), in 2007. That drug has given him over four years of life, and I believe that he may experience a similar benefit from this new treatment.”
For a distraught and discouraged Cumming, “it doesn't add up. Darcy has absolutely nothing to lose.” Given his previous success with immunotherapy when his brain cancer reduced significantly, “We see no risks at this point; without this drug he will die,” she declares.
To help Darcy, please sign his online petition at www.change.org/HelpSaveDarcy , over 180,000 people have, visit www.facebook.com/HelpSaveDarcyNow and contact Bristol-Myers Squibb at 800-332-2056.
For more information contact:
Rebecca Cumming Douglas Boyce