Incyte’s Pemazyre (pemigatinib) Receives MHLW Approval for Myeloid/Lymphoid Neoplasms

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Incyte’s Pemazyre (pemigatinib) Receives MHLW Approval for Myeloid/Lymphoid Neoplasms


  • The MHLW has approved Pemazyre (selective FGFR inhibitor) for myeloid/lymphoid neoplasms with FGFR1 fusion. The approval was based on the results from the P-II study (FIGHT-203) evaluating Pemazyre (13.5mg, qd continuously or intermittently) in 41 patients aged ≥18yrs.
  • The results showed that patients treated with Pemazyre achieved investigator-assessed CRR was 62.5% while CRR in the continuous dosing population was 66.7%
  • Pemazyre is approved for use in the US for the same indication; in Japan for unresectable BTC with an FGFR2 fusion gene & for MLNs with FGFR1 rearrangement; in the EU for LA or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement

  • Ref: - incyte | Image: - incyte
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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