Europe fast tracks rival myeloma drugs from Takeda, Abbvie and BMS

Two rival treatments for multiple myeloma have been granted ‘accelerated assessment’ by Europe’s medicines regulator.

The EMA’s accelerated assessment is similar to the FDA’s Breakthrough Therapy Designation, being reserved for medicines deemed to be of ‘major public health interest and, in particular, therapeutic innovation’.

Takeda’s ixazomib is being developed to treat patients with relapsed and/or refractory multiple myeloma. Meanwhile Empliciti (elotuzumab) from AbbVie and Bristol-Myers Squibb has received the same status for use in combination therapy in adult patients who have received one or more prior therapies (essentially the same patient group as ixazomib).

Both drugs have novel mechanisms: Takeda’s drug is the first oral proteasome inhibitor to enter late-stage trials, while Empliciti is a new immunotherapy, a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody.

The drugs have also shown similar promise in their trial data: both have already shown superior results to Celgene’s market leading Revlimid (lenalidomide) + dexamethasone in respective phase 3 trials published earlier this year.

Empliciti also has data from a phase 2 open-label study (CA004-009) looking at its use in combination with Velcade (bortezomib) and dexamethasone versus bortezomib and dexamethasone alone.

Analysts EvaluatePharma forecast Takeda’s drug could achieve $1.1 billion in sales by 2020, which would help the Japanese carve out a significant presence in haemato-oncology for the first time.

The analyst tips Empliciti for more modest sales, however, of around $711 million by 2020.

Both drugs have already been granted FDA Breakthrough Therapy Designation, with final FDA judgement on Takeda’s drug expected within four weeks.

The rival drugs are likely to reach the market around the same time, but will face competition from other recent and forthcoming drugs to the fast-evolving therapy area. One such competitor is Amgen’s Kyprolis, which has just gained FDA approval as a second line treatment for patients with relapsed myeloma.

 

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