Yes, keytruda is an anti-PD-1 immunotherapy....basically an engineered antibody that targets a specific protein such as PD-1 in this case. There is a good wiki on PD-1 as a drug target. Finally was approved for lung cancer about a month before my dad passed away, but wouldn't have helped him given that supplies were low and by law the drug must be used to treat the corresponding clinical trial volunteers, especially the placebo group. Anti-PD-1 and anti- PDL-1 therapies are important arrows in the anti-cancer quiver. Next up are immunotherapy agents that halt and reverse (yes reverse) cancer metastasis.
No not red tape. When drugs are first approved, they are not yet manufactured in large quantities. It takes a good 6months to spool up production, packaging, marketing, sales and distribution. So because of the 'slow rolling' launch, existing patients get top priority. It's a rather large financial commitment to launch a drug and big pharma has learned to stage everything, but don't pull the trigger until the FDA approval letter is in hand. Often patients will know about new drugs/therapies coming down the pipeline before the oncologists. Good ones will know about clinical trial recruitment, but if they have patients responding to a current treatment, they will not promote their wards to be guinea pigs. The reasoning is because they don't know who will end up in the control group and get placebo. This was the case with my dad....good response to one drug when these immunotherapy agents were recruiting phase3 trials. He chose to stick with the odds he had rather then to take a 50-50 ticket. He did the right thing for himself at that time. Looking ahead, cancer will continue to be far more manageable, with some notable exceptions.
...I know it's a big investment but still, when something like this shows obvious signs of being effective I think the Feds should actually help speed up things for a change. I mean there are people out there dying with little hope of surviving otherwise...what have they got to lose?...and they could give 2 shits about control groups? ...just venting.
This exists as part of the FAST TRAC program for first in class drugs for diseases wherethere is no suitable alternative. Not perfect, but the FDA has gotten better over the years. But at $2.5B cost to launch a new drug, vs past.....there is no better graphic to support tort reform.
...not disputing the current costs but those escalating costs are partly due to government regulations, so the government itself is partly to blame. ...instead, I think our government, if they were truly acting in the best interest of their people, should be more involved and actually help expedite something like this. ...hell, they have their fingers in everybody's pie anyway, and $2.5 Bil is nothing compared to the money they waste. ..."promote the general welfare..." ...again, just venting my dis-satisfaction...I think we can/could do better.
Ron I'm the last guy to support the govt, but in this case you have to look at tort laws. The preclinical cost jump consists of issues related to more challenging research environment (difficult targets), but also new and expensive technologies. However, the clinical testing side are the killer because that's essentially the same process as in the 70s. There the difference is the work done to hedge against class action lawsuit. If govt could reform these regulations, then you'd see more fast track launches and more drugs launched frankly. I say the latter because no company is investing $2.5B on a drug that makes <$250M/yr (assume an avg of 10 yr of patent life left at launch). That's a lot of medicine left untouched, and why so many people are pro-medical marijuana because the is a panacea for much that falls under this threshold.
...believe me, I realize the obstacles that pharmaceutical companies face...f'n lawyers...therein also lies much of the problem. ..."Hurry now...dial 1-800-BAD DRUG"
