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Daiichi starts challenging Astellas for Japanese AML market

Vanflyta is for patients with relapsed/refractory acute myeloid leukaemia

Daiichi Sankyo has begun selling Vanflyta (quizartinib) in Japan for use in patients with relapsed/refractory FLT3-ITD acute myeloid leukaemia (AML).

Japanese authorities approved the oral FLT3 inhibitor in June on the strength of data from a global pivotal trial. The trial linked Vanflyta to statistically significant improvements in overall survival over chemotherapy in a subset of AML patients with FLT3 gene mutations.

When paired with data from a midphase trial of Japanese patients, the results proved compelling enough to secure Daiichi an approval in its home market.

The approval and this week’s launch give Daiichi the chance to start recouping some of the $315m it paid to acquire Ambit Biosciences in 2014. Vanflyta was the focus of the takeover.

Daiichi’s attempts to grow Vanflyta into a significant product will put it in competition with Astellas Pharma, which won approval for its FLT3 inhibitor Xospata in Japan a little more than one year ago.

Daiichi wants to compete with Astellas for the US market as well but was knocked back by the FDA earlier this year. Following the recommendation of its advisory committee, FDA issued a complete response letter for Vanflyta in June.

The briefing document prepared by the FDA ahead of the advisory committee meeting identified concerns with the design and execution of the clinical development programme. As the agency saw it, the shortcomings may ‘impact the interpretation of the study results to a degree that renders them unreliable’.

Daiichi responded to the complete response letter by stating it would evaluate the FDA’s comments before deciding on the next steps in the US.

The decision may be informed by the competitive dynamics in the US, where Astellas’ Xospata competes with Novartis’ Rydapt for the 25% of AML patients with FLT3 gene mutations. That makes the US a more competitive market than Japan.

Daiichi hopes to quickly move past the difficulties Vanflyta has faced in the US by introducing a series of other cancer drugs. If everything goes according to plan, Vanflyta will be the first of seven new molecular entities to emerge from’s Daiichi oncology pipeline between now and 2025.

The company will need to perform better in the clinic than in the past to hit that target. Daiichi has suffered a clutch of cancer setbacks in recent years, including the 2014 failure of an anti-EGFR asset and the 2016 wipeout of patritumab.

Article by
Nick Taylor

10th October 2019

From: Research

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