FDA Approves Nivolumab in Adjuvant Setting - Is it a Big Deal?
By Louise M. Perkins, Ph.D., MRA Chief Science Officer | 21 December 2017 In News, Science, Treatment
The US FDA approved the use of nivolumab (Opdivo) in the adjuvant setting on December 20, 2017. This means that nivolumab may be used to treat melanoma patients with lymph node involvement or metastatic disease after complete surgical resection to reduce the risk of their disease recurring.
Introducing Clinical Trial Navigator: Start Searching Today
At MRA, we know that advancing science is our best bet in the fight against melanoma. More than 87,000 people in the US will be diagnosed with melanoma this year, and with these numbers on the rise, researchers are working harder than ever to find new and better treatment options. In fact, there are over 300 clinical trials happening in melanoma right now.
Connecting the Dots – Clinical Trials and Patient Engagement
MRA is thrilled to announce the launch of the Melanoma > Exchange, a melanoma treatment and research focused discussion group and support community. Through the Melanoma > Exchange, anyone touched by Melanoma can find support, ask questions, and build community among people who share a similar experience.
“Hands down, I’m alive today because of clinical trials”
Jamie Goldfarb didn’t think of herself as having cancer. Yes, she had been diagnosed with Stage II melanoma four years earlier and Stage III the following year, but the surgeries to remove it had been successful. The PET scans that followed had been normal. This wasn’t supposed to be happening. Jamie was now a tired new mom with an eleven-week old baby and she was ready to get back to work. But, her world would turn upside down when she learned that not only was melanoma back, but it had progressed to Stage IV and spread to her liver and pancreas.
Changing the Status Quo: Four Landmark Studies and their Implication for Melanoma Treatment
The crown jewel of the Melanoma Research Alliance has always been—and will always be—good science. Through science, we not only gain a better understanding of melanoma, but the ability to translate that understanding into better treatments, which in turn lead to a better quality of life for people with melanoma. At MRA, solid scientific leadership is at the forefront of everything we do. That’s why the MRA Board of Directors was thrilled to hear a presentation by fellow Board member and world-class researcher, Dr. Suzanne Topalian, on four landmark studies and their implications for melanoma treatment.
Ten Years of Powerful Research and Results
In 2007, when Debra Black was diagnosed with Stage II melanoma, there were few treatment options. In fact, for those diagnosed with late-stage melanoma, only two FDA-Approved treatment options existed, and they only provided a 16% chance at five-year survival. After dealing with her own health concerns, she and her husband knew that they could-and needed- to do more. That’s why later that year they worked with Mike Milken to found MRA and transform the melanoma landscape.
MRA Raises Millions of Dollars for Groundbreaking Melanoma Research
Normally, when people are at a Sotheby’s auction, they come to bid on beautiful and rare art. On Nov. 2nd, however, more than 240 people came together at Sotheby’s Headquarters in New York City to raise their paddle in the fight against melanoma. Together, participants raised over $20 million to further advance melanoma research.
“Seeing his Family Grow-Up Thanks to the Promise of Clinical Trials”
In August 2012, T.J. Sharpe walked into the emergency room with a fever. He’d been ill for a couple of days and didn’t want to get his four-week old son sick if he could avoid it. Sixteen days later, he left a full 30 pounds lighter and with a stage IV melanoma diagnosis.
Safe and Sound: Balancing Safety with Innovation in American Sunscreens
Currently, Americans have access to 16 sunscreen active ingredients approved by the Food and Drug Administration (FDA) to prevent skin cancer. The last time a new OTC (Over the Counter) sunscreen ingredient was added to the FDA sunscreen monograph was 1999. Meanwhile, Europeans have access to 29 sunscreen active ingredients. In the United States there are currently eight new sunscreen ingredients that are pending FDA review, which have been used in Europe – many for over ten years. These new, and potentially better, active ingredients could allow sunscreens to last longer and provide better full spectrum coverage that could help us reverse trends of increasing melanoma incidence in this country. Unlike in Europe where sunscreens are classified as cosmetics, in the United States the FDA is required to evaluate all active ingredients in sunscreens as OTC drugs. Meaning, that all U.S. sunscreen ingredients must be found generally recognized as safe and effective (GRASE) in the same manner as other OTC medications. The FDA says that this is critical to keeping us safe, but is it possible to balance innovation and safety?
Spotlight on Immunotherapy: Genetic Makeup of Tumors Informs use of anti-PD-1 drugs for Multiple Cancer Types
By Pooja H. Rambhia, MD Candidate, Case Western Reserve University | 6 October 2017 In News, Science, Treatment
Imagine the powerlessness one must feel after undergoing rigorous treatment for cancer only to find that your tumor is non-responsive. However – new hope may be on the horizon. In May 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Pembrolizumab for treatmentof patients whose cancers possess a genetic mutation in the mismatch repair pathway (mismatch repair deficient, or dMMR) or are microsatellite instability-high (MSI-H). This is the first time the agency approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.