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: Businesswire | Image: Incyte
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