Breakthrough Therapy Designation for RP1 and RP1 BLA submitted to the FDA under the Accelerated Approval Pathway
“Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens,” said Sushil Patel, Ph.D., CEO of Replimune.
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“CTT2274 has a unique structure and linker that maximizes tumor uptake and allows for release of the chemotherapeutic drug only within the tumor cell thus minimizing potential side effects from the chemotherapy. No other prodrug like this is being developed for prostate cancer and CTT2274 holds great promise as a
“HLX22-GC-301 is a double-blind, randomized, controlled multicenter phase 3 study aims to compare the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab as first-line treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced or metastatic
“We are encouraged by the consistent complete response rates observed in our expanded patient cohort,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These results highlight the potential of ANKTIVA to transform the treatment landscape for patients with BCG-unresponsive NMIBC CIS, offering hope
“The collaborative End-of-Phase 2 meeting with the FDA represents another important milestone in our IMNN-001 clinical program, and we are very pleased that the Agency is aligned with the potential for IMNN-001 to address a significant unmet need in ovarian cancer treatment and our Phase 3 plans,” said Stacy Lindborg,
