Unmet needs in CCA — 3 of 3
ESMO Clinical Practice Guidelines provide key recommendations for managing CCA
Molecular analysis should be carried out before or during 1L therapy to evaluate options for second and higher lines of treatment in advanced disease12
TREATMENT ALGORITHM BASED ON ESMO GUIDELINES12
*Not yet EMA approved but FDA approved; †Clinical trial recommended when available; ‡Molecular profiling should be performed before/during 1L therapy. Gene panel should include FGFR2, IDH1, HER2/neu and BRAF to test for hotspot mutations, but may also include genes such as NTRK and c-MET; §Cisplatin–gemcitabine ± durvalumab is recommended for 1L treatment; consider gemcitabine monotherapy in patients with a compromised performance status or significant debility who are at risk of toxicity from platinum-containing chemotherapy regimens; ‖Reconsider surgery in the event of adequate response to treatment; ¶EMA and FDA approved; **Drug will be permanently discontinued from 31 March 2023;2 ††EMA approved for MSI-H/dMMR BTC and FDA approved for all MSI-H/dMMR solid tumours; ‡‡Anti–PD-1 therapy is recommended for patients with MSI-H/dMMR who have not been treated with 1L immunotherapy; §§Not yet EMA approved and not yet FDA approved.
Date of preparation: January 2023
- PEMAZYRE® (pemigatinib) Swissmedic Professional Information, November 2022; https://www.swissmedicinfo.ch/ (accessed 16 December 2022).
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- Liu PCC, et al. INCB054828 (pemigatinib), a potent and selective inhibitor of fibroblast growth factor receptors 1, 2, and 3, displays activity against genetically defined tumor models. PLoS One. 2020;15:e0231877.
- Abou-Alfa GK, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: A multicentre, open-label, phase 2 study. Lancet Oncol. 2020;21:671–84.
All references are available upon request
Abbreviated Prescribing Information
▼ This medicinal product is subject to additional monitoring. For further information, see product information Pemazyre on www.swissmedicinfo.ch/.
Revision date: November 2022.
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