BLA Review for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) by FDA remains pending
“Although toripalimab’s BLA review process has been impacted by the COVID-19 pandemic, we believe the impact is temporary,” said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences. “Together with our partner Coherus, we are working with the FDA to expedite the facility inspection so it may be conducted safely as soon as possible in order to provide NPC patients with a treatment that has been demonstrated to be safe and effective. Our production operations are well prepared for the inspection.”
Share:
More News
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase
“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to
Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”
“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said
