U.S. FDA Fast Track Designation for Zotatifin in Combination with Fulvestrant and Abemaciclib for Treatment of ER+/HER2- Advanced Metastatic Breast Cancer

“We’re grateful to receive this Fast Track designation from FDA, which is a meaningful milestone for the development of zotatifin and reflects the demonstrated potential for zotatifin in combination with fulvestrant and abemaciclib to address unmet needs in ER+/HER2- breast cancer,” said Steve Worland, Ph.D., chief executive officer of eFFECTOR. “We value the opportunities provided by Fast Track designation for frequent interactions with the FDA review team as we advance this development program for zotatifin, and look forward to providing further data updates and development plans at the 2023 San Antonio Breast Cancer Symposium.”

Share:

More News

“At Boundless, we’re committed to delivering innovative therapies for patients with oncogene-amplified cancers through disciplined execution,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. “By prioritizing the novel combination of BBI-355 and BBI-825, along with our exciting Kinesin program, BBI-940, we’re concentrating our resources where we see

“Most of the PMB-102 trial participants relapsed after CD19 CAR T therapy and/or presented with CD19 negative tumors. PMB-CT01 could present a viable alternative option for patients facing this challenging scenario,” said Hazel Cheng PhD., COO of PMB. “We are deeply committed to the development of this first-in-class BAFFR CAR

“We are encouraged that the two-year follow-up data for Columvi reinforces its potential to extend the lives of many patients where prognosis has historically been poor,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “These findings demonstrate the potential lasting benefits of early and

Søren Bregenholt, CEO of Alligator Bioscience, commented: “The orphan designation to HLX22 in Europe represents another important regulatory milestone for this program. Following the earlier FDA designation, this reinforces the potential clinical and commercial value of the antibody. While Alligator is not directly involved in the development, we look forward