| Pharmaceutical Information |
| Drug Name |
Erdafitinib |
| Drug ID |
BADD_D02506 |
| Description |
In early April of 2019, the US FDA approved Janssen Pharmaceutical Companies' brand name Balversa (erdafitinib) as the first-ever fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy [L5956, L5959]. At the same time, the FDA also approved the therascreen FGFR RGQ RT-PCR Kit (Qiagen) for utilization as a companion diagnostic with erdafitinib for selecting patients for the indicated therapy [L5956, L5959].
Erdafitinib's innovation lies in the fact that it is the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer, which demonstrates the design of erdafitinib in developing more personalized and precision medicines with the capacity to target cancer treatment to a patient's specific genetic mutation [L5956, L5959]. Considering urothelial cancer is statistically the fourth most common kind of cancer in the world [F4372], the introduction of erdafitinib offers a welcome new option in the ever-expanding therapeutic tool kit to treat such prevalent medical conditions.
Nevertheless, although erdafitinib was granted Breakthrough Therapy designation and Accelerated Approval from the FDA so as to allow the agency to focus on and expedite the approval process for a medication indicated for a serious condition that fills an unmet medical need using clinical trial data that is believed to predict a genuine clinical benefit for patients with the given condition, such designations mean further ongoing clinical trials are necessary to confirm the clinical benefit of erdafitinib going forward [L5956, L5959]. |
| Indications and Usage |
Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor [FDA Label][A177109, A177112, A177115] that is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has:
i) susceptible FGFR3 or FGFR2 genetic alterations and has [FDA Label],
ii) progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy [FDA Label].
The selection of patients for the treatment of locally advanced or metastatic urothelial carcinoma with erdafitinib should be based on the presence of susceptible FGFR genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic like the FDA approved therascreen FGFR RGQ RT-PCR Kit as developed by QIAGEN [FDA Label].
This above indication is approved under accelerated approval by the US FDA based on tumor response rate [FDA Label]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [FDA Label]. |
| Marketing Status |
approved; investigational |
| ATC Code |
L01EN01 |
| DrugBank ID |
DB12147
|
| KEGG ID |
D10927
|
| MeSH ID |
C000604580
|
| PubChem ID |
67462786
|
| TTD Drug ID |
D0NW0T
|
| NDC Product Code |
59676-030; 59676-040; 12502-6848; 59676-050 |
| UNII |
890E37NHMV
|
| Synonyms |
erdafitinib | JNJ-42756493 | Balversa |
|
| Chemical Information |
| Molecular Formula |
C25H30N6O2 |
| CAS Registry Number |
1346242-81-6 |
| SMILES |
CC(C)NCCN(C1=CC2=NC(=CN=C2C=C1)C3=CN(N=C3)C)C4=CC(=CC(=C4)OC)OC |
| Chemical Structure |
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| ADRs Induced by Drug |
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*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
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| ADR Term |
ADReCS ID |
ADR Frequency (FAERS)
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ADR Severity Grade (FAERS)
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ADR Severity Grade (CTCAE)
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| Acute kidney injury | 20.01.03.016 | 0.000224% | | | | Illness | 08.01.03.091 | 0.000381% | | Not Available | | Taste disorder | 17.02.07.029; 07.14.03.004 | 0.000246% | | Not Available |
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