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Celgene, Agios get FDA OK for leukaemia drug Idhifa

Duo’s drug becomes first new AML therapy since Novartis' Rydapt

Celgene

Celgene and Agios Pharma have claimed FDA approval for Idhifa, a new drug that is targeted at patients with a specific genetic mutation.

Idhifa (enasidenib or AG-221) has been cleared for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients with an IDH2 mutation, a group that accounts for somewhere between 8% and 19% of all AML patients.

The new drug is an isocitrate dehydrogenase-2 (IDH2) inhibitor, which works by blocking a number of enzymes which promote cell growth. A companion diagnostic from Abbott Labs that detects mutations in the IDH2 gene in blood or bone marrow samples has been approved alongside the new drug.

Celgene - which has priced the new product at almost $25,000 per month before discounts and says patents typically stay on the drug for around four months - has said Idhifa could develop into a $500m product at peak. It has launched the drug immediately on approval, becoming the first new drug specifically approved for AML by the FDA since Novartis' Rydapt (midostaurin).

The decision to approve the drug was based on the results of a study of 199 participants with relapsed or refractory AML with IDH2 mutations. It was found that after a minimum of six months of treatment 19% of patients experienced complete remission for a median of 8.2 months, and 4% achieved complete remission with partial haematologic recovery for a median 9.6 months.

At the beginning of the study, 157 of trial subjects required regular blood or platelet transfusions to help manage the disease, but after treatment with Idhifa a third of them no longer required those interventions.

At Celgene, enasidenib will slot into its blood cancer therapy portfolio alongside Vidaza (azacitidine), a drug used first-line to treat AML patients who cannot receive a stem cell transplant, which made $608m in sales last year.

"Idhifa is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation," said Richard Pazdur, acting director of the FDA's Office of Hematology and Oncology Products. "The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions," he added.

For Agios, the approval is a boost to its aspirations for in-house-developed IDH1 inhibitor AG-120, which was formerly partnered with Celgene but returned as part of a re-structuring last year of the two firms' R&D collaboration. That kicked off in 2010 with a $130m upfront payment from Celgene to Agios.

Analysts at Leerink said: "This is the first drug to emerge from Celgene's collaboration with Agios, and from Agios' research platform in cancer metabolism, and also the first drug to be approved from Celgene's networked research arrangements."

They said the approval of Idhifa lowers the regulatory risk for AG-120 - also known as ivosidenib - which is also in trials for AML and is due for filing before the end of the year.

A phase III trial of ivosidenib in combination with Vidaza in newly-diagnosed IDH1-positive AML patients is in the pipeline, according to Agios.

Article by
Phil Taylor

3rd August 2017

From: Regulatory

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