Universal API Implementation Guide
1.1.20 - ci-build
Universal API Implementation Guide - Local Development build (v1.1.20) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Type | Release to Production |
Available in QA (test) environment? | Product(s) impacted | linkId impacted (if applicable) | OLD | New | Comment |
|---|---|---|---|---|---|---|---|
| ADD | 6/26/26 | Yes | Tecentriq | linkId: tecentriq-fda-approved-indications | - | valueCoding.code: mibc valueCoding.display: Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. TECENTRIQ may be used alone as a treatment for your bladder cancer: - to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and - small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that TECENTRIQ is right for you. It is not known if TECENTRIQ is safe and effective when used: - in children younger than 2 years of age for the treatment of ASPS. - in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. |
NEW bladder indication for Tecentriq |
| ADD | 6/26/2026 | Yes | Tecentriq Hybreza | linkId: tecentriq-hybreza-fda-approved-indications | - | valueCoding.code: mibc valueCoding.display: Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. TECENTRIQ HYBREZA may be used alone as a treatment for your bladder cancer: - to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and - small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that TECENTRIQ HYBREZA is right for you. It is not known if TECENTRIQ HYBREZA is safe and effective in children: - younger than 12 years of age or who weigh less than 88 pounds (40 kg) for the treatment of ASPS. - in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. |
NEW bladder indication for Tecentriq Hybreza |