How Long Does the FDA’s Real-Time Oncology Review Program Take to Approve New Drug Applications?

[6357axbz]

In findings from the phase III TITAN trial on which the supplemental new drug application (sNDA) was based, apalutamide plus androgen deprivation therapy (ADT) significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) compared with placebo and ADT in this patient population.

[pjoshea13]

The FDA can move really fast in the case where a study has shown survival benefit in patients who have run out of options. It's a risky strategy for a drug company to do a study using mCRPC men who have failed chemo, but the rewards are great if there is a survival benefit. It's a quick foot-in-the-door that might lead to approval for larger populations that have not exhausted options.

In the case of Apalutamide [Erleada], it was already approved for non-metastatic CRPC in February of last year. But is there a case for fast-tracking for metastatic non-CRPC, where there are numerous options? "Fast Track designation must be requested by the drug company.":

fda.gov/patients/fast-track...

-Patrick

[pjoshea13 in reply to pjoshea13]

& here is the definition of the FDA Priority Review:

fda.gov/patients/fast-track...

-P.

[6357axbz in reply to pjoshea13]

Patrick, you do understand this application is for mCSPCa, correct?

[pjoshea13 in reply to 6357axbz]

Yes,

I hadn't had my coffee yet.

-Patrick

[6357axbz in reply to pjoshea13]

Based on the positive results this seems better than Abiraterone. Do you agree?

[pjoshea13 in reply to 6357axbz]

Your link has SPARTAN data, but not TITAN (as far as I can see).

[6357axbz in reply to pjoshea13]

You’re right! Interestingly, while they don’t provide quantitative results for TITAN they do state:

“In January 2019, Janssen announced that due to these data from a preplanned analysis, along with a recommendation by an Independent Data Monitoring Committee, the study had been unblinded.2 Based on the positive results favoring apalutamide, the committee recommended that patients on the placebo/ADT arm be allowed to cross over to the apalutamide arm. Patients will continue to be followed for OS and long-term safety as part of the TITAN trial.”

Apparently they are getting some positive results....

[pjoshea13 in reply to 6357axbz]

"Full findings from the study will be presented at the 2019 ASCO Annual Meeting." ... MAY 31-JUNE 4, 2019

[6357axbz in reply to pjoshea13]

Thanks for chiming in Patrick.

[6357axbz in reply to pjoshea13]

If the TITAN trial results were so positive they switched participants on the placebo to the apalutimide side why the hell are they stating that but not publishing quantified results? Is this just PR and the results are only marginally positive over other approved therapies?

[6357axbz in reply to pjoshea13]

targetedonc.com/news/apalut...

[j-o-h-n]

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Good Luck, Good Health and Good Humor.

j-o-h-n Friday 05/03/2019 7:08 PM DST