NMIBC definition
Examples of NMIBC in a sentence
On May 23, 2022, ImmunityBio announced the submission of a BLA to the FDA for N-803 plus BCG for the treatment of BCG-unresponsive NMIBC CIS with or without Ta or T1 disease.
Although such designations may not lead to a faster development process or regulatory review and may not increase the likelihood that a product candidate will receive approval, N-803, ImmunityBio’s novel antibody cytokine fusion protein, has received Breakthrough Therapy and Fast Track designations in combination with bacillus ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇ (BCG) from the United States (U.S.) Food and Drug Administration (FDA) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS).
The Parties acknowledge and agree that (a) Sesen has initiated the submission of a BLA with the FDA for a Licensed Product for the treatment of BCG-unresponsive NMIBC, and (b) the Licensed Compound has potential additional uses within the Field.
Adstiladrin is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇ (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
If either Party desires to initiate Development activities for the use of the Licensed Compound or a Licensed Product for the prevention or treatment of cancer other than NMIBC or its subtypes, such Party shall notify the other Party in writing and the Parties shall negotiate in good faith any necessary amendments to this Agreement, including the Development Plan, to account for such Development activities.
I authorize he holder of medical or other information about to release to the Social Security Administration or its agents any information need for this or a related Medicare claim.
For bladder cancer Procedures which should only be carried out in the host hospital of the specialist team: • Management of high risk non muscle invasive bladder cancer (NMIBC) – the roles of the local urology multidisciplinary team and the specialist urology multidisciplinary team should be explicitly defined in the agreed network guidelines • Radical surgery (cystectomy).