It had previously given the therapy a conditional marketing authorization for CTCL patients who had at least one earlier systemic treatment.
Adcetris’ approval was recommended by scientists at the European Medicines Agency in November of last year. In Europe, regulatory approval requires an endorsement by the agency, followed by a formal approval by the commission.
“The approval of Adcetris in this setting brings a much-needed, effective treatment option to patients living with CTCL, and I am looking forward to be able to offer this treatment to CD30-positive patients who have received one prior systemic therapy,” Dr. Julia Scarisbrick, a dermatologist from University Hospital Birmingham in the United Kingdom, said in a press release.
“Today’s approval is an important milestone for the CTCL community in Europe, and further reinforces the role Adcetris may have in improving outcomes and quality of life for patients with CD30-positive malignancies,” added Jesus Gomez Navarro, vice president and head of Oncology Clinical Research and Development at Takeda, Adcetris’ maker.
Takeda is developing Adcetris together with Seattle Genetics.
Data from the Phase 3 ALCANZA trial (NCT01578499) convinced regulators of the treatment’s value. Study participants were randomly assigned either Adcetris as the only medication, or physicians’ choice of methotrexate or Targretin (bexarotene).
The study included patients with the two most common types of CTCL — primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides.
It had an open-label design, allowing both patients and study staff insight into the way the treatment was allocated.
The overall response rate, lasting at least four months, was 56.3 percent among Adcetris-treated patients, but only 12.5 percent among controls. The difference was seen in both disease subtypes. Overall response includes both full and partial responses to a treatment.
In addition, 16 percent of Adcetris-treated patients had their cancer eradicated, compared with only 2 percent in the standard treatment group, according to the study’s findings, published in The Lancet.
Progression-free survival and symptom reduction were also significantly better in the Adcetris group. Progression-free survival is the amount of time it takes for a disease to progress.
“The clinical data that supported this approval are exceptionally strong. We are proud to be the company to bring a novel treatment option with impressive efficacy and a manageable safety profile to appropriate CTCL patients in the European Union,” Navarro said.
Adcetris is an antibody-drug conjugate that targets the CD30 molecule. The factor is found in skin lesions in about half of all CTCL patients, although the current trial recruited only patients whose tumors produced CD30.
Several of the researchers said Adcetris had the potential to address the psychosocial effect of the skin cancer caused by disfiguring lesions.
“CTCL is a subtype of non-Hodgkin lymphoma that primarily involves the skin; it typically presents with red, scaly patches or thickened plaques of skin that often mimics eczema or psoriasis and can have a substantial impact on patients’ self-esteem. There are few approved CTCL treatment options with only limited efficacy, creating a significant unmet need for these patients,” said Scarisbrick, who was involved in the research.
Susan Thornton, CEO of the Cutaneous Lymphoma Foundation, agreed.
“As a distinct subset of non-Hodgkin lymphoma, cutaneous lymphoma is generally visible on the skin, and can cause significant discomfort. This can result in serious emotional distress and impacts quality of life for patients who are afflicted,” she said.
“There is no known cure, and only a few new treatment options have been introduced over the last several years. This is a welcome new treatment option for cutaneous lymphoma patients in Europe.”
The U.S. Food and Drug Administration extended its approval of Adcetris to CTCL patients with this and another common disease subtype (pcALCL) in November 2017.