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FDA panel backs cancer treatment that saved Emily Whitehead

by on July 20, 2017 8:56 AM

PHILIPSBURG — A miracle in the making since 2010 may save thousands of young lives come September, should the Food and Drug Administration approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer.

That miracle is represented by 12-year-old Emily Whitehead, of Philipsburg.

On July 12, Emily’s parents, Tom and Kari Whitehead, testified at a conference in Washington, D.C., to the life-saving treatment their daughter received. They wanted to tell their daughter’s story in an attempt to sway an FDA panel to recommend the procedure for worldwide use.

And, it worked. The panel approved the recommendation by a 10-0 margin.
With the recommendation, which likely will be approved by the FDA, T-cell therapy, a form of immunotherapy, could be used worldwide in as soon as 60 days.

“It was truly an amazing process and something I’ve been bugging them (the FDA) about for years,” said Tom Whitehead. “I wanted to speak at this hearing when the time came because I truly believe in the procedure. I’ve seen it work. When I was accepted to speak, it was truly one of the most inspirational moments in my life.”

The FDA appointed a 10-member panel, comprised of doctors and industry experts with no financial stake in the procedure. For an entire day, Tom Whitehead said these panelists were grilled by industry leaders concerning the treatment. There was also a period in which patients were able to talk to the panelists about the success they had with the treatment.

Whitehead used his opportunity to tell the story of Emily, and how her continued strength and faith, coupled with this innovative procedure, overpowered the cancer cells in her body. He also discussed the importance of making the procedure accepted by the medical community worldwide, and how it would save thousands of young lives from deadly cancers.

Whitehead said the most impactful moment of the speech came when Emily walked onto the stage to stand beside her father near the end.

“I wasn’t sure if she was going to come up like that, but she has shown strength beyond any child I’ve ever known. I immediately broke down,” said Whitehead. “Of course, that’s the part the national news cameras captured.”

He said the panel convened quickly after his speech, and within minutes, through an electronic tally, a unanimous 10-0 vote to approve the procedure for recommendation was announced.

“I didn’t have any words,” Whitehead said. “I was truly speechless. Something that we worked so hard for was finally going to come true.”

He said after the session, he enjoyed the company of several of the panelists over dinner and social time. He said one of the panelists, a pediatric oncologist, said, “This is the biggest thing I’ve ever seen happen in my lifetime.”
Whitehead said, through discussions with industry professionals, the FDA accepts 98 percent of recommendations made by appointed panels.

“We’re very proud of Emily for all she has gone through, and we’re extremely appreciative of all the doctors who helped us along the way,” said Whitehead. “This has been a long time coming, but finally, we’re going to be able to save thousands of young lives across the world. Kari and I are very proud parents of the pioneering efforts our little girl has suffered to see through.”
 

EMILY’S STORY

Emily is a three-time cancer survivor alive today because of T-cell therapy. She was the first child patient in the world to receive the treatment in 2012, after relapsing following other treatments. Her initial diagnosis with acute lymphoblastic leukemia was made in 2010, at the age of 5.

Typically, children diagnosed with this type of leukemia have an 85 to 90 percent chance of being cured; however, Emily relapsed in October 2011. A bone marrow transplant was scheduled for February 2012, but Emily relapsed again just weeks before the transplant date. Her leukemia was so aggressive that doctors felt they had run out of options and recommended that she go home on hospice care.

But the Whiteheads were not ready to give up. They caught wind of a revolutionary new treatment that had just become available at Children’s Hospital of Philadelphia and enrolled Emily in a Phase I clinical trial to have her immune system trained to fight cancer. The process involved collecting her T-cells (a type of white blood cell), then genetically reprogramming them through the use of, interestingly, the HIV virus, to recognize and attack cancer cells. These modified cells were then infused back into Emily’s blood.

The treatment caused Emily to become very sick and she spent the next two weeks in an intensive care unit, that first night beating the odds of survival of 1 in 1,000, according to the doctor in charge. After her treatment, Emily slipped into a coma, which was reversed by yet another experimental procedure — the introduction of an arthritis medicine called tocilizumab. Slowly, she recovered, and a few weeks later, the family, her doctors and, most importantly, Emily, realized she was cancer-free.

This spring, Emily celebrated her 12th birthday. She also celebrated being cancer-free for five years, a monumental date for cancer survivors.

Since Emily’s treatment five years ago, technology has advanced the procedure, which has now treated 200 pediatric patients in the United States. Doctors said the procedure has around a 90 percent success rate with an initial remission, and 55 to 60 percent of patients who underwent the treatment are now past one year of being cancer-free.
 

EMILY WHITEHEAD FOUNDATION

In 2015, the Whiteheads officially established the Emily Whitehead Foundation, a nonprofit organization with a mission of raising awareness for pediatric cancer, as well as for raising funds to help grow the cancer-fighting T-cells.
“It’s a very, very expensive procedure,” Tom Whitehead said. “Even now, it’s all still new and this kind of work and technology costs a lot of money. We want to help as many people as we can, so of course, that means we need to help raise a lot of money. Every little bit helps.”

The foundation also serves as a home base for the knowledge the Whitehead family has gained along the way. And, it has created some important friendships.

In its first year, the foundation raised more than $100,000, which was donated to grow more T-cells for cancer patients. In 2016, the foundation doubled its efforts and raised more than $200,000.

Emily’s treatment gained worldwide attention, and her story has appeared in The New York Times, Forbes, PARENTS Magazine, the Stand-Up-to-Cancer Telethon, HBO Vice and the PBS documentary "Cancer: The Emperor of All Maladies" by Ken Burns. A three-minute documentary about her treatment called "Fire With Fire," by Academy Award-winning director Ross Kauffman, is available on YouTube.
The Whiteheads continue to keep a busy schedule. Emily continues her studies at the Philipsburg-Osceola Middle School as a sixth-grader, while Tom is busy working as a lineman with Penelec. Kari Whitehead works in research at Penn State University.

“We’re never sitting still for very long,” Tom Whitehead said.
Tom and Kari Whitehead, and sometimes Emily, travel the country speaking at events and advocating research for pediatric cancers.

TEE OFF FOR T-CELLS

Two days after testifying in Washington, the Whiteheads were back in their hometown for the annual Tee Off for T-cells Golf Tournament, held at the Philipsburg Elks Lodge and Country Club.

With drenching rain showers impacting fairways and greens, golfers were limited to playing a nine-hole round of golf to support the Emily Whitehead Foundation.

The event drew 92 golfers. Celebrities on hand included tournament host Jon Condo, the Oakland Raiders’ long-snapper and a Philipsburg native; State High and Penn State alumnus Nate Stupar of the New Orleans Saints; and former Nittany Lions Kerry McCoy, the University of Maryland's wrestling head coach, and Austin Johnson, of the Tennessee Titans.

With a nine-hole score of 28, the event was won by the foursome of Jason, Todd and Brandon McCliment and Matt Ammerman.

Besides the golf outing, a silent auction was held with prizes that included a three-night stay at The Inn at Spanish Bay, one round at Pebble Beach (two people), one round at Spanish Bay (two people) and two tickets to any home Raiders game (excluding Dallas). The vacation packages were sponsored by the Oakland Raiders. Other prizes included stays at NIZUC Resort & Spa in Cancun, Mexico; a stay at a Myrtle Beach condo; and two World Series tickets, donated by MasterCard.
Whitehead said Condo helped him come up with the idea of a golf tournament.

“I want to use the power of being a National Football League football player to help raise awareness of such a heartbreaking disease that too many of our children experience,” Condo said.

The tournament was sponsored by CNB Bank, Canuso, SIG, JJ Powell, Lee Industries, Veritas and First Energy Foundation.

“We wanted to do something special in Philipsburg because of the fantastic support they have given Emily since her diagnosis and Jon Condo throughout his athletic career,” Whitehead said.

A new event has been added to the foundation’s calendar with the inaugural Emily Whitehead Foundation Believe Ball, scheduled for Saturday, Oct. 28, at Valley Forge Casino Resort in King of Prussia. The event will bring together the children, families, physicians, researchers and others working to advance immunotherapy cancer research.
For more information, visit www.emilywhiteheadfoundation.org.

Gazette correspondent John Dixon contributed to this article.

 

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