FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations
“This designation by the FDA highlights the importance of developing novel therapeutic options for patients living with EGFR-mutated nonsquamous non-small cell lung cancer,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We believe ADCs are an important modality in the treatment of cancer and are rapidly advancing the clinical development of sacituzumab tirumotecan, with the goal of meaningfully improving upon current standards of care in certain cancers.”
Share:
More News
“T-cell engagers targeting CD3 have successfully exploited the first signal in T-cell receptor signaling to treat liquid tumors, significantly expanding the treatment options for these cancers. However, solid tumors represent a much greater unmet clinical need that has yet to benefit from advances in immune-engaging bispecific antibodies,” said Nathan Trinklein,
“We are pleased to advance the clinical development of ADRX-0706 into the Phase 1b dose expansion cohorts,” said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. “Encouraging findings from our Phase 1a trial demonstrate the best-in-class potential for ADRX-0706, with differentiated safety and pharmacokinetic properties, including a much
“The BOND-003 monotherapy data underscores our novel investigational oncolytic immunotherapy’s unique product profile, including its dual mechanism of action, which we believe differentiates it from current and investigational NMIBC treatments,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “Based upon the latest data, we are confident that cretostimogene
“Receiving a second FDA Fast Track Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options,” stated Panna Sharma, President and CEO of Lantern Pharma. “Recent data presented at the Immuno-Oncology
