World Head and Neck Cancer Awareness Day has generally been rated a major success by organisers and observers alike; however, the news isn’t all great. Being aware is one thing and certainly helps in overcoming the disease, but straight medical treatment is the big gun and latest tests on one of the biggest calibre guns - the immunotherapy drug Keytruda -are not promising. Then there’s a story about U.S. insurance company blues which suggests battling bureaucracy is a universal challenge.
On a brighter note consider:
"Disney's original Snow White has got a good small mining business going, a loyal workforce she takes care of - why does she need a prince to come and save her? If she stays off the apples, she's all good."
Merck Drug Shows No Life-Extending Benefit in Head-and-Neck Cancer
(U.S.) The first immunotherapy approved in the U.S. to treat head and neck cancer has failed a big test, but it’s unclear if the FDA will exercise its right to pull it from the market.
Merck (NYSE: MRK) announced that its blockbuster cancer drug pembrolizumab (Keytruda) did not meet its main goal of helping people live longer in a key trial, dubbed KEYNOTE-040. The FDA gave pembrolizumab a fast-track approval last August based on a subset of the 040 data that showed the drug was shrinking tumors. But the agency required positive results in the future, including evidence of a survival benefit over standard chemotherapy.
The approval is for patients with head and neck squamous cell carcinoma that has returned or spread to other parts of the body after treatment with chemotherapy.
The FDA approved nivolumab (Opdivo), from Merck’s top immunotherapy rival Bristol-Myers Squibb (NYSE: BMY), for the same patient population last November. Bristol’s approval was based on data that showed nivolumab improved survival by a median of 2.4 months over chemotherapy.
Merck said today that pembrolizumab’s approval for head-and-neck cancer is not in immediate danger of being revoked. “We have already discussed these data with the FDA and do not anticipate any changes to the current indication at this time,” a Merck spokeswoman told Xconomy via email.
Merck did not release data except to say that pembrolizumab did not meet its primary endpoint of overall survival. Merck also said that “no new safety signals were identified” and that the level of side effects was consistent with other pembrolizumab studies. It will discuss the data later at an unspecified medical meeting. The spokeswoman also noted that pembrolizumab was currently being studied in two other head-and-neck cancer trials; she declined to speculate whether data from those trials would factor into the drug’s continued approval.
Head and neck cancer kills more than 9,000 Americans a year, about the same as skin cancer. The top U.S. cancer killers are lung, colon, breast, and prostate cancers, according to the Centers for Disease Control.
Pembrolizumab is also approved for certain types of skin cancer, bladder cancer, lung cancer, lymphoma, and for patients with tumors that have a specific genetic fingerprint—the first time a drug was approved for a cancer’s genetic profile instead of the cancer’s organ or tissue of origin.
Cancer-patient advocacy group says 'Fight cancer, not me'
(JACKSONVILLE, Fla. )- Many patients fighting cancer are also battling insurance companies' policies and processes that make it difficult or even impossible to receive proton radiation therapy that their doctors prescribe, according to the advocacy group Alliance for Proton Therapy Access.
Believing patients should be able to receive quick answers and fair treatment from insurance companies when faced with a cancer diagnosis, the group has started a campaign, "Tell Insurers: Fight Cancer, Not Me," and a petition drive.
"All cancer patients deserve access to the best available cancer treatment recommended by their physicians," the group wrote on its website. "Too many patients, however, experience insurance company delays and denials when their doctors recommend proton therapy. Proton therapy is an advanced form of radiation therapy that offers patients fewer side effects and improved quality of life."
Kathy Brooks has worked in oncology nursing for more than 30 years, and at Ackerman Cancer Center since 2015, so she understands exactly how difficult cancer treatment can be. When she was diagnosed with tongue cancer in 2016, she knew she needed proton therapy.
“Because of my experience as an oncology nurse, I knew that treatment for head and neck cancer is very difficult," said Brooks. "Proton therapy was my best chance to survive and have quality of life, but unfortunately my insurance did not approve it. Going forward with my proton treatment, I had to fight the cancer and with the insurance appeals process every step of the way.”