$ImmunityBio (IBRX.US)$This is a summary of a professional p...
$ImmunityBio (IBRX.US)$This is a summary of a professional press release in the biotechnology and healthcare field. The following is its Traditional Chinese translation:
Translation content
ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that it recently held a Type B end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA). The meeting discussed the company’s submitted supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC) patients with papillary tumors who are unresponsive to BCG.
ImmunityBio provided a summary of the clinical status of its papillary disease program, including over five years of follow-up data supporting the papillary tumor indication. Key highlights are as follows:
* Disease-Specific Survival (DSS): Approximately 96% at 36 months, with the median survival not yet reached even after five years of follow-up.
* Cystectomy Avoidance Rate: The one-year and three-year cystectomy avoidance rates were as high as 92% and 82%, respectively.
* Safety: The safety profile is consistent with the currently approved 'Carcinoma In Situ (CIS) with or without papillary tumor' indication.
In addition, several authoritative urologists attending the meeting presented real-world treatment approaches for BCG-unresponsive patients; in such cases, the remaining alternative is often only radical cystectomy.
Core Terminology Analysis
| Original Term | Professional Translation | Description |
|---|---|---|
| Type B End-of-Phase meeting | Type B End-of-Phase Meeting | A critical meeting between the development company and the FDA to discuss Phase II clinical results and plans for entering Phase III or filing for market approval. |
| sBLA | Supplemental Biologics License Application | An application for an already approved drug to add new indications or methods of use. |
| BCG-unresponsive NMIBC | BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer | A type of bladder cancer that has developed resistance to standard BCG therapy. |
| Cystectomy | Bladder removal surgery | Traditionally, if BCG treatment is ineffective, the entire bladder usually needs to be surgically removed.
Translation content
ImmunityBio (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that it recently held a Type B end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA). The meeting discussed the company’s submitted supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC) patients with papillary tumors who are unresponsive to BCG.
ImmunityBio provided a summary of the clinical status of its papillary disease program, including over five years of follow-up data supporting the papillary tumor indication. Key highlights are as follows:
* Disease-Specific Survival (DSS): Approximately 96% at 36 months, with the median survival not yet reached even after five years of follow-up.
* Cystectomy Avoidance Rate: The one-year and three-year cystectomy avoidance rates were as high as 92% and 82%, respectively.
* Safety: The safety profile is consistent with the currently approved 'Carcinoma In Situ (CIS) with or without papillary tumor' indication.
In addition, several authoritative urologists attending the meeting presented real-world treatment approaches for BCG-unresponsive patients; in such cases, the remaining alternative is often only radical cystectomy.
Core Terminology Analysis
| Original Term | Professional Translation | Description |
|---|---|---|
| Type B End-of-Phase meeting | Type B End-of-Phase Meeting | A critical meeting between the development company and the FDA to discuss Phase II clinical results and plans for entering Phase III or filing for market approval. |
| sBLA | Supplemental Biologics License Application | An application for an already approved drug to add new indications or methods of use. |
| BCG-unresponsive NMIBC | BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer | A type of bladder cancer that has developed resistance to standard BCG therapy. |
| Cystectomy | Bladder removal surgery | Traditionally, if BCG treatment is ineffective, the entire bladder usually needs to be surgically removed.
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