FDA approves Keytruda for all solid tumors w specific biomarker

Oh WOW Beth. I really hope this may offer Gary some further hope and remission. We will be keeping every single thing crossed for you both. I was not expecting this update - amazing news for all those cancer sufferers in the US - a new ray of (much needed) hope.
Hugs to you both.
Jaybee&GG

Oh wow, Beth. This is fantastic. Please keep us posted! Donna.

It is reported that this is the first time a cancer drug has been approved for use based on a bio-marker and not the cancer origin. Certainly an advancement.

The information I found is that the drug is approved for situations that are presented with solid tumors, the specific bio-marker, and no other viable treatments are available. Injections and/or infusions are administered generally every three weeks and can continue for up to 24 months, according to the article. Cost of about $150,000 per year. Don't know if that is MSRP or reimbursement amount. That will probably vary among insurance companies. I have not found any information specific to PCa or from insurance companies or Medicare regarding when it will be covered.

My reading was from a news article and the FDA news release.

That is so awesome!!!!

One suggested correction in the post headline.

Keytruda is not approved for all cancers. It is approved for cancers that have solid tumors and the patient has a specific bio-marker. The bio-markers listed are PD-L1, MSI-H and dMMR. By interacting with these the drug better enables the body's natural immune system to kill the cancer. The cancers that often have these bio-markers include colorectal, gastrointestinal and endometrial. Some prostate cancers are endometrial.

There will be many cancers that it is not approved for such as blood cancers that don't produce solid tumors. Plus there will be many that have solid tumors, but do not have the bio-marker, thus it would not be appropriate. So far it has been used successfully with some forms of melanoma, non-small cell lung cancer, some head and neck, some colorectal cancers, Hodgkin lymphoma and urothelial cancers. One study I saw showed some very good results in about 60% of men with PCa, but the study only covered a handful of men. The famous report we saw a couple of years ago was the wonderful response former President Carter demonstrated which alleviated brain lesions caused by melanoma.

I see two main aspects of this approval. First, that it was in the process with many different trials and there was enough positive results observed that the FDA did not wait until each trial was complete to make a specific approval. That speeds up access by many years. That type of approval is not unusual. Second, the approval for use is not based on original site of the cancer. Rather it is based on the presence of the bio-marker regardless of the cancer origin. This has never been done before and could signal a different method of approving immunotherapy drugs for cancer.

I hope I have this information and terms correct as I was reading from several different reports including the news release from the FDA.

Of course, if you can push $150,000 CASH across the table, you can get any kind of drug you want......YOU decide whether it was effective of not...

Sorry, I misunderstood. If not, he might be eligible for Cohort A (Keytruda+Lynparza) which has a site in San Francisco. It doesn't require any molecular analysis to qualify, but it does disqualify men with myelodysplastic syndrome - I don't know if Gary has that.

www.healingwell.com/community/default.aspx?f=35&m=3681010&p=1

Beth(and Gary)
Keep looking for that glimmer of hope, keep celebrating life, keep the Faith! Possibly the best medicine is not one backed by studies and facts and data and trial after trial, but one that lies within your own belief.

Thanks for posts about your journey, that will help others, including me immeasurably! Remembering Jody Feeks story, it became etched into my mind. She was a very brave, courageous, and strong person, just as you and Gary are, Beth. My prayers are for you both, always.

Tall one-thanks for that factual background about that announcement. What I like is the apparent advancement of approval by the FDA, and can only hope this trend continues. Always hoping for new discoveries of treatments that actually work more effectively, for any cancers, so this announcement is indeed good news.

JNF-Thanks also for that information on the subject
.
Also praise to the MO Docs that have the courage to prescribe such drugs off label if they believe it to be effective. Wish the insurance approvers could see the light!
Wings

Post Edited (Wings of Eagles) : 6/2/2017 10:39:20 AM (GMT-6)

beth and gary! this is such great news and has put a smile on my face despite the terrible week we've had with my dad's cancer. i hope it's suitable and works for gary! i'm so glad he's up to trying! good luck and love to both of you x

JNF-

The urothelial indication for Keytruda is separate from the indication for "microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors."

My understanding is that Medicare must by law cover all FDA-approved indications for drugs (and they may not negotiate pricing). That law does not apply to private insurance companies. And it does not apply to procedures, items, services and diagnostics, all of which may be determined by CMS nationally, or by MACs regionally. So, for example, for a C11 Choline PET scan, which is FDA approved, it is up to the regional MAC whether they will cover it. But the NaF PET scan is disapproved nationally unless it is in conjunction with a clinical trial or registry. And the FDG PET scan is approved nationally, even though it is of little use in all but very advanced cases.

In the UK, MHRA (similar to our FDA) determines whether new drugs are safe and effective, but NICE determines whether they are cost-effective, and they may negotiate prices. Only drugs that are approved by NICE are covered by the HHS.

TA

I just read a paper from the Hudson Institute by Gerald Dorros that indicates the FDA approval for safety and effectiveness is separate from the CMS approval based on reasonable and necessary to treat conditions. It indicates that the CMS does not have to reimburse just because the FDA approves the use. Think of all the elective FDA approved cosmetic procedures that neither Medicare nor private insurance reimburses because that are not necessary.

I just consulted the Medicare reimbursement conditions and codes for Keytruda. It looks like it is covered under Part D as a drug. There would also be potential coverage under Part A or B for the administration depending on the hositilization status. These were last updated in March 2917.

It lists very specific types of cancer as has been reported and is very limited. Interestingly, it does not include urothelial prostate cancer though Aetna does. So there are time when Medicare and private insurance do not converge.

We will have to wait and see how Medicare approaches the recent approval.