EU Approves Adcetris for Certain Types of Cutaneous T-cell Lymphoma
The European Commission has approved Adcetris (brentuximab vedotin) as a treatment for adults with cutaneous T-cell lymphoma (CTCL) whose cancer produces the CD30 molecule.
It had previously given the therapy a conditional marketing authorization for CTCL patients who had at least one earlier 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.
Read more: http://bit.ly/2BtZD7I
It had previously given the therapy a conditional marketing authorization for CTCL patients who had at least one earlier 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.
Read more: http://bit.ly/2BtZD7I