FDA Pipeline: Safety Warning About Investigational Use of Venetoclax in Multiple Myeloma, Warning Letter on Unapproved Products
This week, the U.S. Food and Drug Administration (FDA) posted a safety statement on the investigational use of venetoclax in multiple myeloma, and also posted a warning letter against a company for illegally marketing unapproved products labeled as homeopathic.
Safety Statement
The FDA posted a safety statement to alert health-care professionals and patients about the suspension of a clinical trial of bortezomib and low-dose dexamethasone with or without venetoclax in patients with relapsed and refractory multiple myeloma, due to an increased risk of death for patients receiving venetoclax when it was combined with bortezomib and dexamethasone as compared to the control group.
The FDA has required that patients in the BELLINI trial be discontinued from further treatment, because interim results from the trial demonstrate an increased risk of death for patients receiving venetoclax. Only patients who are deriving clinical benefit will continue treatment in this clinical trial after reconsent. Other multiple myeloma clinical trials of venetoclax and other combinations were also suspended.
Given the serious nature of the safety issue, the FDA reminds doctors and patients that venetoclax is not FDA-approved to treat multiple myeloma. The FDA’s safety alert does not apply to the approved indications for venetoclax, as the safety and efficacy of using venetoclax for approved, on-label uses have been established.
“[This] alert underscores the importance of why new therapies are thoroughly studied to help ensure their benefits outweigh the risks to patients, and we will continue to carefully monitor clinical trials to help ensure patients are protected when safety concerns arise," said FDA’s Center for Drug Evaluation and Research director Janet Woodcock, MD.
Warning Letter
The FDA posted a warning letter to Nutra Pharma Corp for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia, and other serious conditions.
“One of our most important obligations is to protect consumers from those who would prey on them with bogus claims and fraudulent products. We’ve dedicated new resources to our enforcement work and I consider these activities the cornerstone of our consumer protection mission and one of our most significant institutional obligations. We’re especially focused on those who would exploit Americans harmed by the opioid crisis with the false promise of products that can treat pain or addiction, but that offer no such benefit,” said FDA Commissioner Scott Gottlieb, MD. “…We posted a warning letter to a company preying on patients who may be seeking alternative treatments for chronic pain, cancers, arthritis, and autoimmune and neurological disorders. Health fraud scams like these are inexcusable. These patients deserve proven treatments not false promises that can deter them from seeking otherwise effective care, and that can also contain ingredients or contaminations that can threaten their health. We have great concern for the millions of Americans who live with chronic pain or cancer, and for whom traditional treatment options have been exhausted, as well as those battling opioid addiction.”
The FDA issued a warning letter to Nutra Pharma for their products “Nyloxin Oral Spray,” “Nyloxin Topical Gel,” “Nyloxin Topical Roll-On,” “Nyloxin Topical Roll-On ES,” “Nyloxin Professional Size Pump Topical Gel,” and “Regular Strength Sample Pack.” These products also may confuse consumers because its name is similar to FDA-approved drugs.
Examples of claims made include:
- “Nyloxin . . . treats conditions that cause chronic pain.”
- “[C]obra venom saw its primary use in the treatment of cancer and arthritis. Reportedly the venom was used to treat liver cancer, lung cancer, esophageal cancer, skin cancer, and leukemia.”
- “Today, cobra venom is being studied for treating various forms of pain, cancers, autoimmune and neurological disorders.”
The FDA has requested responses from Nutra Pharma within 15 working days. The warning letter also states that failure to correct violations may result in legal action without further notice, including, without limitation, seizure, and injunction.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
