RE:RE:RE:RE:RE:RE:Dr. Chamie Interview - Quilt 3.032 study (N-803 + BCG)
N0taP00p wrote: Eoganacht,
I was curious about the assumption that Theralase can potentially continue treatments beyond the first two. Wouldn't that fall outside the treatment protocol filed with the FDA for phase 2b?
Off-label use is actually pretty common in the medical field, especially in oncology when existing approved therapies often fail individually to meet the demands of cancer patients. This off-label approach is precisely what is currently being employed by many urologists/medical centers for the treatment of high-risk NMIBC (both pre BCG & post BCG treatment failure...& being used in large part due to the BCG shortage).
As per the American Cancer Society website (*see below), PDT is also more amenable to multiple treatments compared to radiation & certain chemo regimens that entail significant side effects.
*Studies have shown that PDT can work as well as surgery or radiation therapy in treating certain kinds of cancers and pre-cancers. It has some advantages, such as:
- It has no long-term side effects when used properly.
- It’s less invasive than surgery.
- It usually takes only a short time and is most often done as an outpatient procedure.
- It can be targeted very precisely.
- Unlike radiation, PDT can be repeated many times at the same site if needed.
- There’s usually little or no scarring after the site heals.
- It often costs less than other cancer treatments.
Note: I'm not suggesting that additional PDT treatments would work for every indication, but one can construe that the potential for such use would be relatively high compared with certain alternatives that are known to be less safe &/or effect less durable responses. One positive I would add that is not mentioned above is the potential for PDT/PS to be used in combo with other treatments. Lastly, the downside of prolonged light sensitivity caused by use of a more traditional PS like Photofrin would no longer exist when using TLD-1433.