The Brussels-based Committee for Medicinal Products for Human Use (CHMP), a unit of the European Medicines Agency, has recommended that the European Commission approve the drug for this condition.
“This opinion represents a crucial first step forward for European patients living with CTCL, a debilitating disease that can have a significant impact on their quality of life,” Dr. Julia Scarisbrick, a dermatologist with England’s University Hospital Birmingham, said in a Takeda press release.
The Japanese company is developing Adcetris along with Seattle Genetics, which holds U.S. and Canadian rights to the drug. Last week, the U.S. Food and Drug Administration approved Adcetris to treat CTCL. The treatment is also approved for various patient groups with classical Hodgkin lymphoma or anaplastic large cell lymphoma.
The CHMP’s recommendation built on data from the open-label Phase 3 ALCANZA clinical trial (NCT01578499), in which Adcetris was compared to various standard-of-care therapies in CTCL patients that produce a factor called CD30.
“The results of the ALCANZA trial demonstrate impressive efficacy along with a manageable safety profile when compared with methotrexate and bexarotene, commonly used therapies,” Scarisbrick said. “If approved in Europe, Adcetris would offer a novel treatment option for CD30-expressing CTCL patients.”
The study showed that patients treated with Adcetris had a better overall response rate, lasting four months or more, than those given other treatments. In fact, 56.3 percent of Adcetris-treated patients had a response of this duration, compared to only 12.5 percent of patients given standard therapies such as methotrexate or Targretin (bexarotene). With this, the study met its primary goal.
Other, secondary, measures — including progression-free survival, a lowering of symptoms and the rate of complete tumor eradication — were also highly significant, Takeda reported.
The treatment was also considered relatively safe and well-tolerated, and the adverse events during the study were in line with what is already known about Adcetris.
The most common adverse events among Adcetris-treated patients were peripheral neuropathy, nausea, diarrhea, fatigue, vomiting and itch. Some of these reactions were severe.
“Today’s positive CHMP opinion is an important milestone for the CTCL community, and further reinforces the role Adcetris may have in improving outcomes for patients with CD30-positive malignancies” said Dr. Jesús Gómez Navarro, vice president and head of oncology clinical research and development at Takeda. “For patients with CTCL, there is a significant need for additional treatment options that increase the opportunity to achieve durable responses.”
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