Daiichi's Xospata rival pushed back by FDA as it combs through new data

Daiichi Sankyo
The delay for Daichii Sankyo comes amid an executive shake-up with a new CEO and R&D structure for 2019. (Daiichi Sankyo)

Daiichi Sankyo's PDUFA date for its FLT3 inhibitor has been pushed back to late August, as the FDA wants more time to go over new data from the Japanese pharma.

In an update posted this morning, Daiichi said the U.S. review of its blood cancer hopeful quizartinib will be pushed back by three months, with a new action date of Aug. 25. Daiichi’s shares were down 1.3% on the news.

“The FDA extended the action date by three months to allow time to review additional data submitted by Daiichi Sankyo in association with an FDA request,” Daiichi said in a brief statement.


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The drug is seeking approval in patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). It got an FDA priority review in November, which speeds up its regulatory process for a drug.

 “We look forward to continued dialogue with the FDA throughout the review process of quizartinib," said Arnaud Lesegretain, vice president of oncology research and development and head of the AML franchise at Daiichi.

“We remain confident in the data supporting our NDA submission and are committed to bringing quizartinib forward as a potential treatment for relapsed or refractory FLT3-ITD AML, a particularly aggressive and difficult-to-treat subtype of AML, where patients need additional targeted treatment options.”

Marketing applications for quizartinib are also under review in the company's native Japan and in Europe.

RELATED: AstraZeneca puts $6.9B on the table for a Daiichi Sankyo cancer drug

While certainly not a fatal blow to the drug’s prospects, it won’t help its attempt to rival Astellas’ Xospata, another FLT3 drug that last November got U.S. approval for the indication Daiichi will now need to wait longer for.

Earlier this week, Astellas posted new results from its so-called ADMIRAL trial, showing a strong overall survival benefit for its drug over salvage chemo, (9.3 months compared to 5.6 months), with one-year survival rates at 37% for Xospata patients versus 17% for patients who received salvage chemo.

But the Japanese company still has much to smile about. Just a week ago, AstraZeneca penned a pact that could see it spend nearly $7 billion in biobucks on another of Daiichi’s pipeline cancer drugs, namely its lead antibody-drug conjugate, [fam-] trastuzumab deruxtecan (DS-8201), which is in tests for HER2-expressing cancers including breast and gastric cancers as well as in non-small cell lung and colorectal cancers.

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