Cancer and Burn Pits, FDA Updates and Provider A Doctor’s on Medicare
Regarding new drug indications last week, the FDA seemed to be working in the gastrointestinal space: we saw a new drug approved for certain patients with colorectal cancer, and other indication in the gastric cancer space slightly changed from the way it was originally approved a few years ago.
Finally, it is the open enrollment period for people who are eligible for Medicare. We heard from an expert at City of Hope about why patients with cancer should do their research before choosing a plan.
Veteran, Colon Cancer Survivor Explains Importance of PACT Act
Last year, President Joe Biden signed the bipartisan Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act into law last year, with the White House calling it “the most significant expansion of benefits and services for toxic exposed veterans in more than 30 years.”
More than 4.1 million veterans received free toxic exposure screenings through the VA, with the government processing nearly half a million PACT Act claims and delivering more than $1.85 billion in PACT Act-related benefits to veterans and survivors, including $215 million in benefits to veterans with cancer, during the first year of the PACT Act, the White House stated.
Under the PACT Act, for example, all gastrointestinal cancers are considered toxic exposure presumptive conditions — meaning veterans do not have to prove that the cancer started during or worsened because of their military service — for veterans from the Gulf War and post-9/11 eras such as Dan Nevins, a U.S. Army Reserve veteran and stage 3 colon cancer survivor who served in Iraq.
Read more: Veterans On The Front Lines of Lung Cancer
Dan is a bilateral, below-knee amputee living with a traumatic brain injury as a result of his service, and he received his cancer diagnosis in late 2021.
Spoke with us about his experiences being exposed to burn pits in Iraq.
Last week came with another Food and Drug Administration approval in the oncology space. Fruzaqla for patients with metastatic colorectal cancer that has been previously treated with certain chemotherapy drugs, anti-VEGF therapies, and — if the patient has RAS wildtype disease and its medically appropriate — an anti-EGFR therapy.
The approval, which was announced on Wednesday night, was based on findings from two clinical trials: FRESCO and FRESCO-2, which both showed that Fruzaqla improved overall survival (time from treatment until death of any cause) compared to placebo in this patient population.
Of note, Fruzaqla is an oral drug that is not a chemotherapy agent, which may help patients avoid an abundance of clinics for treatment, as well as some of the side effects associated with chemotherapy, though we should note that Fruzaqla, like all drugs, does have its own set of potential side effects.
FDA Amends Keytruda Approval for Gastric, GEJ Cancer
Also on the FDA front, the agency announced on Thursday that it was revising the approval indication of Keytruda plus Enhertu and chemotherapy for the frontline treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
The Keytruda-containing regimen was originally approved in May 2021 and was for patients regardless of their cancer’s PD-L1 status. PD-L1 is a protein found on the surface of tumor cells and acts as a kind of cloak of invisibility from the immune system. Checkpoint inhibitor drugs like Keytruda inhibit the function of PD-L1, thereby allowing the immune system to find and fight the cancer.
With the amended approval, the FDA is now stating that this Keytruda regimen should only be used in patients whose cancers have that PD-L1 protein, as determined by a companion diagnostic test.
This change came after follow-up data from the KEYNOTE-811 trial were presented at the European Society for Medical Oncology Congress a couple of weeks ago. The findings showed that while the Keytruda plus Enhertu and chemotherapy improved outcomes over placebo plus Enhertu and chemotherapy, the benefit was particularly better for those whose disease was PD-L1 positive.
When It Comes to Cancer Care, Not All Medicare Plans Are the Same
The Medicare open enrollment period has officially begun and will run until Dec. 7.
In a CURE® exclusive article penned by Dr. Harlan Levine of the City of Hope, a popular type of Medicare — Medicare Advantage — is outlined, along with their potential pros and cons when facing a cancer diagnosis. For example, did you know what while Medicare Advantage tends to be a more affordable option, it may not cover research medical centers that provide patients with cancer access to advanced treatments and clinical trials?
Dr. Levine and others are advocating for Medicare Advantage to cover treatment at comprehensive cancer centers, but until then, he warns individuals to be weary of the plans that they choose and always read the fine print.