RE:Because of a lack of better treatments...
wildbird1 wrote: Question?
Why keytruda that has a a very low 18%CR and many serious side effects, was accepted by the FDA for Bladder Cancer patients.
In this article dated Jan.10, 2020..
https://gr-cis.com/2020/01/10/mercks-keytruda-approved-for-high-risk-bladder-cancer/ .
Paragraph 5,
Merck said" Keytruda will be a new clinical option for a patients population that previously had limited FDA- Approved therapies available".
Can you believe this... Keytruda with its very low CR% and serious side effects was approved by the FDA for Bladder cancer, because of a lack of better treatments.
TLT time is coming.
Hi wildbird1...
Fortunately for us (unfortunately for patients), the options that are FDA approved are limited to only two...1) Systemically administered Keytruda & 2) Intravesical Valrubicin...both significant underperformers. If our results pan out, we are certainly well-positioned in the front of a very short line to be the new best single-agent option.
Historically, there is a superior treatment protocol to Keytruda that is currently being used by some urologists for both BCG-unresponsive NMIBC & BCG-naive NMIBC. The protocol, however, has yet to be FDA approved. The above treatment is an intravesical option that utilizes two chemotherapeutic drugs, gemcitabine + docetaxel. The protocol has seen an increase in recent use due to not only its superior historical efficacy, but also b/o the recent BCG supply shortages.
The big drawback of the above non-FDA approved option is the fact that it's a very treatment-intensive protocol that includes 6 weekly induction treatments followed by monthly maintenance treatments for up to 2 years for responders. Such a treatment-intensive protocol can obviously be a burden on patients, but it can also disrupt the general workflow in the treating clinic (due to limited clinic space). A recent survey amongst urologists also noted challenges in getting the drugs supplied from hospital pharmacies.
There are a lot of moving parts (including non-FDA approved) in the world of BCG-unresponsive NMIBC. With the right partner, navigating this evolving biotech maze & getting from bench to clinic should be a lot easier. Having a first-mover advantage for our tech shouldn't hurt either : ). As you noted, despite some treatment gains made periodically, there are still too few FDA-approved options that can adequately forestall the need for cystectomy...& perhaps equally important, there are currently no options (FDA or non-FDA approved) that are both treatment & patient-friendly.
I agree...TLT time is on the horizon, & the lights of Vegas are getting brighter. All imo. Good luck...