Well good morning.
Yesterday was my Drug and scan day so it was up at 4.30 to shower and walk the dog and we set off at 5.50. The traffic was very good and we traveled straight through so we arrived at 7.30 far to early but at least we had a very welcomed cup of coffee to wake up fully.
Carol booked me in when we arrived at the ward and not long after Lorraine came to get me and take my bloods.
She phoned up and got my scan changed from 1.10pm to “come up now” Great thats just what I did. 8.30am and I was in the scanning Dept. This was going to be a good day.
The nurse came out straight away and I had my scan at 9am. She wiched me luck as it seems the whole hospital knows and was waiting for the results.
I went back to my ward and the Doctor called me in. The bloods were done and everything was great except for my creatinine levels which were high again.
The kidneys maintain the blood creatinine in a normal range. Creatinine has been found to be a fairly reliable indicator of kidney function. Elevated creatinine level signifies impaired kidney function or kidney disease.
So I have to make sure I drink more water. I know its mt failing even though Ray keeps me supplied with drinks.
I will try and drink more I promised the Doctor.
Other than that she was pleased to order the drug for me.
We went away and had a coffee and a cake. this is our usual treat at the hospital.
Back in the waiting room again we settled down for a long wait but the doctor called me in as she had the results of my scan.
MORE SHRINKAGE. WOW!!!
It can be seen even if they hadn’t measured it yet. Even more has gone back to scarring. This has never been known.
Different Doctors came and were smiling and congratulating me. It just wouldn’t sink in though.
They will do the measurements and in 2 weeks I can get the print off so I will report here as I love reading and sharing the report.
I was able to have my drug and was all finished by 2.30pm So we got off home and had dinner all before 5pm Amazing.
Except when we got home the electricity vans were in the car park and another whole had been dug. We were asked to put our car in the visitors carpark and they bought in a huge generator and parked that in our spot.
Well we didnt have enough power to run a computer last night. I thought it had blown up until Ray reminded me we are on a generator and that will only supply us with the minimum of power. Enough to run a telly and the lights kept going down. No heating –gosh you really miss it when you cant have it.
I was shattered anyway so we went to bed and I must have been asleep before 9pm.
My poor brain is exhausted with all the excitement. I will have been on the drug for a year next month. That year has flown by and Im still here. I would be dead by now but Im not so I will carry-on and report as much as I can about pembrolizumab and what happens to mesothelioma when taking it. I can keep on it the treatment all the time my body copes with it.
Lou in Australia has had good results even after 3 sessions and sh is showing what it does for Malignant peritoneal mesothelioma which type of cancer that occurs in the thin cell walls surrounding the abdominal cavity,
Lou reports — 7.30am back at hospital just saw my oncologist Significant shrinkage of dead mass and big tumour protruding into tummy!! Fantastic news looks like Mavis Nye’s wonder drug Keytruda is slowly working its magic! 3rd dose overnight today in hospital!—————— Great news !!
I hope it continues for her. It isnt on the free list in Australia so she is paying for the treatment. Well Health care is paying for 2 thirds of it.
There are many more that wish to follow her in Australia so they are watching her results. Its not a trial its being used as it is a treatment for melanoma where it has had great success, so as a last result you can go private. I dont know if you can do the same here but it is something worth looking at.
A great report here —–
The next time someone tells you that cancer drug approval is always slow, arduous, and met by huge regulatory snafus, consider this: Merck ’s Keytruda was approved by the U.S. Food and Drug Administration just three-and-a-half years after the first doses of the medicine were given to patients in clinical trials.
The rapid approval, which allowed Keytruda, also known as pembrolizumab, to leapfrog a similar drug from Bristol-Myers Squibb BMY +0.4%, is a triumph for research head Roger Perlmutter, who arrived at Merck 18 months ago and has significantly improved the company’s record of getting drugs through the FDA.
Perlmutter says Keytruda caught his attention instantly. “I’d just never seen anything like it. And fairly quickly I said to people, “You know, any one of you that’s working on a project, if you want to spend a dollar on that project, you’re going to have to explain to me why I shouldn’t be spending it on pembrolizumab. Because to me, that’s the most important thing that we can do and that will have the biggest benefit for patients.”
Instead of advancing the drug to larger studies, Perlmutter expanded the drug’s existing phase I trial , which lacked a control group of patients getting other treatments, to 3,500 patients with a variety of different cancers. The approval was based on 173 patients with advanced melanoma who had been failed by all available treatments. For 41 of them, their tumors shrank, an effect that has lasted anywhere from 1.4 months to 8.5 months. For most of the patients who responded, the tumor shrinkage has persisted.
The approval was also sped, Perlmutter says, by the FDA’s new “breakthrough designation,” which allowed Merck to be in weekly contact with the reviewers who evaluated not only Keytruda’s safety and efficacy but also Merck’s manufacturing processes.
With both Keytruda and another drug, the sleeping pill Belsomra that was approved in August, Perlmutter has been able to get medicines to market faster than analysts on Wall Street expected, smoothing over issues with the FDA and moving quickly. But the question remains of how much revenue these products can actually generate.
For Keytruda, that’s because the drug is only approved for patients with melanoma that has spread who have not been helped by other available medicines. And, thanks to a burst of new drug approvals, there are a lot of them. Five other new melanoma drugs have been approved since the beginning of 2011.
Ten thousand patients in the U.S. develop metastatic melanoma every year. Half of their tumors have a mutation in a gene called BRAF, which means that they are likely to have their tumors shrunk by drugs that target it: Zelboraf, from Roche and Daiichi Sankyo , or a two-drug combination made by GlaxoSmithKline. The other half move on to Yervoy. After the BRAF drugs fail, which they eventually do, they move onto Yervoy, too.
Only after patients have taken Yervoy will they get Keytruda, which works by knocking out a protein called PD-1 cancer cells hijack to hide from the immune system. Even at Merck’s price of $12,500 per patient per month, that is at most a $140 million market opportunity, according to Seamus Fernandez at Leerink.
Bristol-Myers Squibb’s similar drug, Opdivo, is expected to be approved early next year. More importantly, Opdivo could be approved to be used before Yervoy or with Yervoy, meaning it would leapfrog Merck’s entrant.
One big controversy that has surrounded PD-1 blockers is whether some very sick patients should get them before they have been approved. Some patient advocates say that patients should be allowed to try risky but promising medicines because they have little hope. Perlmutter is a defender of the current system.
There’s no doubt that Keytruda does have adverse events, and serious adverse events, associated with its use. And so, for people who are suffering from a malignant disease, they may say – and some do say – “Hey, look: I’ll take that risk.” But if you don’t actually know what the risk is, it doesn’t seem to me that that’s a fair proposition.
Clearly the most compassionate thing that we can do for a drug like Keytruda is to get it on the market so that a learned intermediary – a prescribing physician, an oncologist – can make the decision about whether or not that drug makes sense in a given patient. And that’s exactly the American system. That’s exactly what’s going to happen.