I expect FDA would be interested in duration of re
Post# of 153802
(Total Views: 504)
Posted On: 08/26/2024 7:13:09 PM
I expect FDA would be interested in duration of response in addition to ORR so 3 month trial duration is highly unlikely. If we have stellar results, I'm hoping for accelerated approval with a phase 3 follow on trial for OS and PFS.
A question for Cytodyn's next conference call - Has the potential for an accelerated approval pathway been discussed during the mCRC phase 2 study meeting with FDA?
For reference:
On June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
In the 94 enrolled patients, ORR was 34% (95% CI: 25%, 45%), all responses were partial responses, and median DOR was 5.8 months (95% CI: 4.2, 7.6). Thirty-one percent of responding patients had a DOR of at least 6 months.
https://www.fda.gov/drugs/resources-informati...tal-cancer
A question for Cytodyn's next conference call - Has the potential for an accelerated approval pathway been discussed during the mCRC phase 2 study meeting with FDA?
For reference:
On June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
In the 94 enrolled patients, ORR was 34% (95% CI: 25%, 45%), all responses were partial responses, and median DOR was 5.8 months (95% CI: 4.2, 7.6). Thirty-one percent of responding patients had a DOR of at least 6 months.
https://www.fda.gov/drugs/resources-informati...tal-cancer
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