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Has Opdivo been recently FDA approved for SCLC? I can't find anything on the FDA site or media releases, but someone has said it was approved Monday. Figured if anyone would know, it would be an oncologist!
Take care, Judy
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Reply # - September 11, 2016, 07:56 AM
Hi Judy,
Hi Judy,
I'm not finding anything about an approval for that. The only immunotherapy news I've seen in the last week is with regard to Keytruda in the first-line setting for NSCLC:
"Merck & Co., Inc.’s MRK supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, Keytruda has been accepted for priority review by the FDA.
The company is looking to expand the label into the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1.
With the FDA granting priority review, a response should be out by Dec 24, 2016. Additionally, the FDA granted Breakthrough Therapy designation to the drug for this indication. The sNDA submissions were based on positive data from pivotal phase 3 KEYNOTE-024 study, which showed that Keytruda led to significant improvement in survival in patients with high PD-L1 expression compared to chemotherapy. The drug is also under review in the EU for this indication." - https://www.yahoo.com/news/mercks-lung-cancer-drug-keytruda-152903026.h…
The news release was dated September 8, 2016.
JimC
Forum moderator
Reply # - September 11, 2016, 12:53 PM
Thanks Jim. Kind of odd that
Thanks Jim. Kind of odd that this doctor is telling this patient's family that it's been approved and he'll be receiving it for SCLC and not in a clinical trial. Find this very strange.
Take care, Judy
Reply # - September 11, 2016, 02:52 PM
You're right, Judy. If it had
You're right, Judy. If it had been approved, I'm sure it would be on the FDA site, and the way that drug companies' stocks are followed, it would be in the business news as well.
Any possibility the doctor meant that he expected it to be approved, and was prescribing it off-label?
JimC
Forum moderator
Reply # - September 11, 2016, 04:14 PM
No, she said the doctor told
No, she said the doctor told her it was FDA approved. We all know it is for NSCLC and she insisted it's now approved for SCLC. How likely would it be for insurance to pay for this off-label? Sometimes I just worry that a patient may be used as a guinea pig without benefit of a trial. Probably never know.
Also, have you ever heard of a LC recurrence after 17 years being from the same primary originally diagnosed? How are they able to tell that after so long?
Take care, Judy
Reply # - September 15, 2016, 05:32 AM
Hi Jim, I know you probably
Hi Jim, I know you probably didn't see the last question in my previous post. So I'm trying to bring this back up the ladder! Take care, Judy
Reply # - September 15, 2016, 06:16 AM
Hi Judy,
Hi Judy,
Sorry I missed your follow-up questions. I would think it unlikely that insurance would cover such off-label usage, absent a good amount of evidence of its efficacy (and even then probably not). When my late wife was in the last few months of her disease, Abraxane had not yet been approved in lung cancer, but when her oncologist (GRACE contributor Dr. Thomas Hensing) provided her insurer with a significant amount of trial evidence showing its efficacy, they agreed to cover it. That turned out to be very helpful, as she avoided nearly all of the usual side effects of taxol, but I think the approval was the exception rather than the rule.
I can't say I've heard of a specific case with recurrence after 17 years; at the very least it would be rare, as Dr. West described:
"Most of the recurrences that are ever going to occur will be in the first 2 or 3 years. The risk after about 4 years is only in the range of a few % per year after that, in the range of the risk of a new cancer. After 4-5 years, the main reason many of us recommend yearly CT scans (not everyone does, as there is no clear rule for how to do long-term follow-up) is to detect a new cancer, not find a recurrence of the old one.
We loosely use the term cure to describe 5-year disease-free survival, but in truth there are a small percentage of recurrences that occur late. Those tend to be the lower grade, slower progressing cancers. Aggressive cancers will occur early or not at all. More indolent cancers can recur many years later, even 10 or more years out from surgery. Bronchioloalveolar carcinoma (BAC) tumors typify this class (although many BACs aren't that indolent)." - http://cancergrace.org/forums/index.php?topic=510.msg2614#msg2614
The only way to determine if a new finding is a recurrence or a new cancer is by comparing the original pathology with that of the new nodule.
JimC
Forum moderator