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Takeda bags EU approval for Adcetris in lymphoma

Data shows the drug improves PFS and symptom burden in CTCL patients

Takeda

The European Commission has expanded the approved indication for Takeda’s cancer drug Adcetris, giving the nod to second-line use of the drug in CD30-positive cutaneous T-cell lymphoma (CTCL).

Adcetris (brentuximab vedotin) - a CD30-targeting antibody drug conjugate (ADC) - already has conditional approval in the EU for certain adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma, but the new indication expands the eligible patient population for the drug.

CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often looks like eczema or chronic dermatitis.

The approval is based on the results of the phase III ALCANZA trial, which revealed a statistically significant improvement in proportion of patients experiencing an objective response lasting at least four months on Adcetris, as well as improvements in median progression-free survival (PFS) and overall response rate, and symptom burden.

“There are few approved CTCL treatment options with only limited efficacy, creating a significant unmet need for these patients,” said dermatology specialist Julia Scarisbrick of University Hospital Birmingham, UK.

“The approval of Adcetris in this setting brings a much needed, effective treatment option to patients living with CTCL,” she added.

Originally developed by Seattle Genetics, Adcetris has been on the market for just over six years and has seen sales grow steadily to around $600m last year, driven by a stream of new indications, and according to the biotech has the potential to cross the $1bn sales threshold. It filed for US approval in CTCL last August.

In Europe, Adcetris is also approved for CD30-positive Hodgkin’s lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and when post-ASCT patients are at high risk of relapse.

It’s additionally approved for relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior chemotherapy regimen.

There are more new indications on the way, and Takeda and Seattle Genetics recently reported a positive phase III read-out in first-line Hodgkin’s lymphoma (the ECHELON-1 trial) and is also waiting on results in first-line mature T-cell lymphoma, often referred to as peripheral T-cell lymphoma (ECHELON-2).

The ECHELON-1 data were reported at the American Society of Hematology (ASH) meeting in December and showed that Adcetris plus chemotherapy was more effective at extending PFS that chemo alone.

Approval in first-line Hodgkin’s as a combination therapy with chemotherapy could open up a substantial new market for the drug and, according to Seattle Genetics, “could define a new standard of care in this patient population after more than four decades”.

The biotech is anticipating launches in the first half of this year after filing for US approval at the end of 2017, as the FDA has awarded both breakthrough status and a priority review to the application.

Article by
Phil Taylor

23rd January 2018

From: Regulatory

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