Du verden, dette er da både oppsiktsvekkende og svært interessant for oss Photocure-aksjonærer.
ODAC (Oncology Drugs Advisory Committee) stemmer altså i en 9-4 vote for å godkjenne Keytruda for high-risk non-muscle invasive bladder cancer (NMIBC).
Men blant de 4 som stemte i mot var altså begrunnelsen at det den målte Complete Response rate på 19% trolig var for høy siden det ikke ble brukt Cysvie i studien.
Og vi vet jo at Cysview er spesielt viktig for nettopp gruppen med high risk patients, ref resultat fra surveilance studien.
"The sNDA filing contains data from a Phase 3 clinical study comparing the detection of bladder cancer recurrence in patients undergoing surveillance cystoscopy in the outpatient setting. Results from this prospective, 17 center study with 304 patients showed that in patients undergoing surveillance cystoscopy, BLC with Cysview detected bladder cancer recurrence in 20.6% of the patients that otherwise would have been missed with white light (WL) alone, which is highly significant (p<0.0001). The study also showed that 34.6% of the patients with carcinoma in situ (CIS), a very aggressive form of bladder cancer, were detected with only BLC with Cysview but missed with white light cystoscopy (p<0.0001). "
Argumentasjon fra de som var mot godkjennelse av kanskje verdens mest kjente kreftlegemiddel med hundrevis av milliarder dollar i årlige inntekter er svært interessant promotering av Cysview.
“Blessed by the designation, Merck is expecting an FDA decision by January 2020. But before that, it will need to make a case before an independent FDA oncology expert panel on Dec. 17, a procedure not common for a label expansion application for an approved therapy.”
Nå blir nok Keytruda mest sikkert godkjent som legemiddel etter å ha passert ODAC hinderet, men det gjenstår 1 hinder, godkjennelse fra FDA. Så det er altså ikke sikkert at Keytruda blir godkjent i denne indikasjonen.
For the record ODAC (Oncology Drugs Advisory Committee) er altså en AdCom (Advisory Committee)
" A study published Sunday in the Milbank Quarterly journal found that around 80 percent of the time, Food and Drug Administration decisions regarding drugs and devices were in accordance with the recommendations from advisory committees, also known as AdComs; about 20 percent of the time they were not. The study looked at 376 AdCom meetings regarding 298 products or product classes that took place between 2008 and 2015."
“It was slightly more common for the FDA to reach decisions more cautious or restrictive than AdCom recommendations than it was for the agency to be less cautious, the study found. In 23 percent of cases when an AdCom gave a favorable recommendation, the FDA reached a decision that was more restrictive, while the agency reached decisions less restrictive than AdCom recommendations in 19 percent of cases.”
I januar får vi altså vite om Cysview indirekte har klart å stikke kjepper i hjulene for Keytruda.
Men om Keytruda mot formodning ikke skulle få denne godkjennelsen så kommer altså begrunnelsen å være at Merck ikke har satt opp sitt kliniske studie godt nok når de har unnlatt å bruke Cysview.
