TG Therapeutics Announces FDA Accelerated Approval of UKONIQ? (umbralisib)

Endpoint per IRC | UKONIQ MZL (n=69) | UKONIQ FL (n=117) |
ORR, n (%) | 34 (49) | 50 (43) |
95% CI | 37.0, 61.6 | 33.6, 52.2 |
Complete Response, n (%) | 11 (16) | 4 (3.4) |
Partial Response, n (%) | 23 (33) | 46 (39) |
Duration of Response | ||
???????? Median, months (95% CI) | NR (9.3, NE) | 11.1 (8.3, 16.4) |
???????? Range, months | 0.0+, 21.8+ | 0.0+, 20.9+ |
CONTACT: | |
Jenna Bosco | |
Senior Vice President, | |
Corporate Communications | |
TG Therapeutics, Inc. | |
Telephone: 877.575.8489 | |
Email:?ir@tgtxinc.com |
