Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan
Executive Summary
Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.
Daiichi Sankyo is not seeking to persuade the European Medicines Agency to change its mind on its refusal to recommend quizartinib for approval across the EU as treatment for relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).
It seems the Japanese company is planning instead at a future date to file for approval of quizartinib in first-line use in AML – depending on the results of the Phase III QuANTUM-First trial that is under way. Its sights are set on the EU and the US.
The EMA’s drug evaluation committee, the CHMP, adopted a negative opinion in October regarding the marketing authorization application for quizartinib in adult patients with r/r FLT3-ITD AML. (Also see "Daiichi Sankyo’s AML Drug Among Nine CHMP Hopefuls" - Pink Sheet, 15 Oct, 2019.) (Also see "First Ebola Vaccine Among Seven Products To Get EMA Nod" - Pink Sheet, 18 Oct, 2019.)
The new drug application for the product in the US had been rejected by the Food and Drug Administration a few months earlier, in June. Quizartinib was approved that same month in Japan, under the brand name Vanflyta. It was launched in Japan on 10 October. (Also see "AML Contender Quizartinib Gains First Approval, In Japan " - Scrip, 20 Jun, 2019.) (Also see "Quizartinib Looks Like A Good Drug, ODAC Says, But Needs Another Efficacy Trial Before Approval" - Pink Sheet, 14 May, 2019.)
Daiichi Sankyo confirmed to the Pink Sheet that it had not requested a re-examination of the CHMP's negative opinion.
"Enrollment into QuANTUM-First is completed and we will evaluate the results to determine next steps for regulatory submissions for quizartinib in newly-diagnosed FLT3-ITD AML" – Daiichi Sankyo
The company said: “We do not have plans to appeal at this time but continue to consider feedback from the regulatory agencies. We look forward to the results of QuANTUM-First, our global pivotal phase 3 study evaluating quizartinib combined with standard chemotherapy in patients with newly-diagnosed FLT3-ITD AML. Enrollment into QuANTUM-First is completed and we will evaluate the results to determine next steps for regulatory submissions for quizartinib in newly-diagnosed FLT3-ITD AML.”
It said it remained “committed to bringing quizartinib forward as a potential treatment option for this aggressive and difficult-to-treat subtype of AML in the US, Europe and other parts of the world.”
The US and EU regulatory submissions for quizartinib were based on results of Daiichi’s pivotal Phase III QuANTUM-R study, which compared quizartinib monotherapy with salvage chemotherapy.
The ongoing QuANTUM-First trial has an estimated primary completion date of November 2020. It is evaluating quizartinib in combination with standard induction and consolidation therapy and as maintenance monotherapy in patients with newly-diagnosed FLT3-ITD-positive AML.
The company said: “We are conducting additional research and analyses to help inform clinical use as well as further development of quizartinib, as demonstrated in the three oral presentations at ASH featuring post-hoc analyses from the global pivotal phase 3 QuANTUM-R study.”
ASH, the American Society of Hematology annual meeting, will take place in Orlando, Florida from Dec 7-10.
Datamonitor Healthcare analyst David Dahan commented: “QuANTUM-R did not fail and the rejection was likely due to regulatory authorities wanting to wait for a second positive Phase III trial. The approval of Xospata [Astellas Pharma’s gilteritinib] reduced the medical need for a FLT3 inhibitor for the relapsed/refractory setting and meant that the authorities did not feel rushed to approve quizartinib.” (Also see "Astellas Gets Europe Okay For AML Drug Xospata" - Scrip, 28 Oct, 2019.)
Daiichi Sankyo declined to comment on why the Japanese regulatory authorities chose to approve Vanflyta while those in the US and the EU did not.