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FDA clears Takeda's oral multiple myeloma drug

Ninlaro is the first oral proteasome inhibitor to get a green light from the FDA

Takeda has been given approval to market its multiple myeloma drug Ninlaro in the US, the first oral proteasome inhibitor to get the go-ahead by the FDA.

Ninlaro (ixazomib; formerly MLN9708) has been cleared for use in combination with Celgene's immunomodulatory drug Revlimid (lenalidomide) and dexamethasone in patients with the blood cancer who have been treated with at least one prior therapy.

Approval of the orally-active drug gives myeloma patients an alternative to injectable proteasome inhibitors such as Takeda's own market-leading Velcade (bortezomib) and Amgen and Onyx' Kyprolis (carfilzomib), and could open up a new market for the drug class as maintenance therapy for myeloma.

Ninlaro also has a sizeable lead in the market compared to other oral proteasome inhibitors as its closest rival - Amgen/Onyx' oprozomib - remains in clinical development.

Takeda needs the new drug to gain traction quickly however as Velcade loses patent protection in the US in 2017 and is projected by Datamonitor to lose $1bn in sales by 2020. It is already being challenged in the market by Kyprolis in the wake of new data suggesting improved progression-free survival (PFS) versus Takeda's drug.

FDA approval is based on the results of a 722-patient clinical which compared Ninlaro in combination with lenalidomide and dexamethasone to placebo plus lenalidomide and dexamethasone. Those taking Ninlaro lived longer without their disease worsening - an average of 20.6 months - compared to 14.7 months in participants taking the control regimen.

The green light comes just days after the FDA approved Johnson & Johnson's Darzalex (daratumumab), a new first-in-class injectable drug for multiple myeloma that can be used in patients who have been treated with at least three prior therapies.

It is the third drug for the disease approved this year, as Novartis got a green light for Farydak (panobinostat) - the first HDAC inhibitor to be approved for myeloma - back in February for use in patients who have received at least two prior treatment regimens.

Having three new first-in-class therapies is a big step forward for patients as multiple myeloma remains an incurable disease, with almost all patients eventually developing resistance to current therapies."The approval of ixazomib offers a much-needed additional option in the multiple myeloma treatment landscape," said Kathy Giusti, executive chairman of the Multiple Myeloma Research Foundation (MMRF).

"A cancer diagnosis today is different from what it was just a few years ago and it's exciting to see continued progress," she added.

The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the US this year.

Article by
Phil Taylor

23rd November 2015

From: Regulatory



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