We take a look at the first FDA approval in the oncology space for 2024, the Lymphedema Treatment Act and more.
It wasn’t even two weeks into the new year when the Food and Drug Administration made their first FDA approval. In this case, it was a Keytruda regimen for certain patients with gynecologic cancers. We at CURE® spoke with the primary investigator on the study leading to the approval about what patients need to know about the latest new indication.
Topics discussed:
Also last week, we highlighted the Lymphedema Treatment Act and spoke to an expert about the new law.
Another story in the regulatory space: the FDA granted a Fast Track designation to speed up the review of a novel drug used to treat patients with relapsed or refractory CLL or SLL.
Finally, research from the American Cancer Society showed that Medicaid expansion states tended to have improved post-surgical outcomes in patients with non-small cell lung cancer.
The Food and Drug Administration has granted approval for Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of stages 3 to 4A cervical cancer, marking the first approval of an anti-PD-1 therapy with chemotherapy for this patient population and the third FDA approval for treating cervical cancer with Keytruda.
This week, I spoke with Dr. Linda R. Duska, a gynecologic oncologist and principal investigator on the study leading to the approval, who discussed the KEYNOTE-A18 trial, which enrolled 1,060 patients and demonstrated a 30% decrease in progression for those receiving the combination of Keytruda and chemotherapy. The overall survival data is not yet mature, but the treatment showed a 41% reduction in the risk of disease progression or death. While Dr. Duska emphasized that cervical cancer is preventable thanks to a safe and effective vaccine, she said that for patients with the disease, this new regimen is particularly exciting.
January is also Cervical Cancer Awareness month, so definitely stay tuned to curetoday.com for more of our coverage on the disease.
The Lymphedema Treatment Act, signed into federal law on Dec. 23, 2022, is now in effect as of Jan. 1, 2024, allowing Medicare coverage for doctor-prescribed compression supplies for patients experiencing. The bill encompasses standard and custom-fitted gradient compression garments and other approved items prescribed by healthcare professionals to treat lymphedema. Now basically what that means is that patients insured by Medicare Part B can now have their lymphedema garments covered by insurance.
This coverage is expected to ease financial burdens on patients, especially as these garments can be expensive.
I spoke with Joanna Fawzy Doran, CEO of Triage Cancer, who emphasized the importance of patient and provider awareness about coverage rights, appealing denials and navigating the process. Although the law does not mandate private insurers to cover compression sleeves for lymphedema patients, Doran noted that Medicare's coverage sets a precedent for broader access in the future.
The FDA has granted Fast Track designation to NX-5948, a novel drug, for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously undergone two lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.
Fast Track designation aims to expedite the development and review of drugs addressing serious conditions with unmet medical needs.
NX-5948 is currently in a Phase 1a/1b clinical trial, with initial findings presented at the 2023 American Society of Hematology (ASH) annual meeting indicating safety, tolerance, and clinical activity. The drug showed no dose-limiting toxicities or treatment-related side effects leading to discontinuation, and the most common side effects were purpura/contusion, nausea, and thrombocytopenia.
States with Medicaid expansion tended to have a significant decrease in early, postoperative mortality from non-small cell lung cancer, according to recent research.
The research focused on nearly 15,000 patients undergoing surgery for NSCLC, with 62.1% residing in states supporting Medicaid expansion. The study found notable reductions in 30-day and 90-day postoperative mortality in patients with stages 1, 2, or 3 NSCLC in expansion states. Patients in non-expansion states were found to be younger, non-Hispanic Black, uninsured, and with comorbidities.
The study also evaluated changes in early mortality before and after the Affordable Care Act (ACA) implementation, showing a decrease in the 30-day mortality rate in expansion states from 0.97% to 0.26% after the ACA. Now, advocates, including the American Cancer Society, continue to emphasize the importance of expanding Medicaid eligibility to improve health outcomes.
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