FDA removes partial hold on Telcyta clinical development

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 16 No 11
Volume 16
Issue 11

FDA removes partial hold on Telcyta clinical development

PALO ALTO, California—Telik, Inc. has announced that the FDA has removed the partial hold on Telcyta (canfosfamide HCl) clinical trials. This action follows a complete review of Telcyta data by the agency and permits the resumption of Telcyta clinical development. Telcyta is a tumor-activated small-molecule product candidate in clinical development for the treatment of advanced ovarian cancer and non-small-cell lung cancer. FDA placed the hold on development after phase III data showed lower median survival for women with advanced ovarian cancer receiving Telcyta vs standard chemotherapy.

Recent Videos
Findings from the OVARIO study show that patients with HRR–deficient and BRCA-mutated disease benefitted the most from niraparib/bevacizumab maintenance.
Next-generation clinical trials may address when to use CDK4/6 inhibition in patients with low-grade serous ovarian cancer.
The NRG-GY019 trial will assess chemotherapy plus letrozole vs letrozole alone as a frontline treatment for patients with low-grade serous ovarian cancer.
Nearly 40% of low-grade serous ovarian cancers have RAS alterations, which are predominately KRAS mutations.
Related Content