FDA Fast Track Designation Granted to Soquelitinib for Treatment of Patients with R/R PTCL
“The granting of Fast Track Designation by the FDA highlights the significant unmet need for patients with relapsed or refractory PTCL,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The current treatment options for these patients provide limited efficacy and are associated with significant toxicity, and there are no FDA fully approved agents. There continues to be strong interest in soquelitinib from investigators at sites with deep experience treating T cell lymphomas and we are on track to initiate patient enrollment in our registrational Phase 3 trial in PTCL in the third quarter 2024.”
Share:
More News
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit
“We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade
“Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and
“The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month