Britain’s national health service advisory agency has made a decision that will make Adcetris (brentuximab vedotin) more accessible as a treatment for an aggressive type of lymphoma.
The National Institute for Health and Care Excellence drafted a recommendation that the National Health System cover the Takeda therapy’s use rather than making it available through a special fund. The decision reverses the advisory agency’s initial stand, although it had added a condition to Adcetris’ use.
The recommendation applies to people with relapsed or refractory systemic anaplastic large cell lymphoma, or sALCL.
Jonathan Pearce, chief executive of the Lymphoma Association, said in a press release that the advisory agency’s decision “will bring relief to sALCL patients and their families who, without brentuximab vedotin, would have limited treatment options.”
“It is vital that innovative treatments are being developed and made available to lymphoma patients,” he said. “We want everyone affected by lymphoma to receive the best possible treatment and care, and the more options there are to improve outcomes and quality of life for patients, the better.”
Adcetris targets the CD30 protein receptor on sALCL cells’ surface.
The National Health System began making it available to patients beginning in April 2013 through its Cancer Drugs Fund. The advisory agency decision means Adectris will become more accessible in three months.
A restriction that the advisory agency included in its recommendation will limit Adcetris to lymphoma patients who are able to walk and engage in light activities. These are patients with an Eastern Cooperative Oncology Group performance score of 0 or 1.
“We are pleased with the positive NICE [advisory agency] decision,” said Adam Zaeske, Takeda’s UK general manager. “However it is disappointing that NICE has added a last-minute ECOG [patient activity score] restriction that could result in a small number of patients no longer having access to the medicine and being left with limited options.”
Sixty-six percent of 58 patients with relapsed or refractory sALCL achieved remission of their cancer in a Phase 2 clinical trial (NCT00866047). Eighty-six percent achieved a full or partial response to the treatment, which consisted of doses of Adcetris every three weeks for up to 16 cycles.
A presentation at the American Society of Hematology’s 2016 meeting showed that 60 percent of patients were still alive five years after treatment, and 39 percent had not had their disease progress. This was in contrast with the three-month overall survival rate seen in relapsed or refractory sALCL patients before Adcetris.
“I am delighted that patients can maintain long-term access to brentuximab vedotin through this NICE decision,” professor Tim Illidge of The Christie National Health Service Foundation Trust, said in a press release. “Brentuximab vedotin has transformed the outlook for such patients since it was made available on the CDF [Cancer Drugs Fund] and provides hope of long-term survival and improved quality of life.”
The U.S. Food and Drug Administration is in the midst of reviewing Seattle Genetics’ Biologics License Application for Adcetris as a treatment for cutaneous T-cell lymphoma, including sALCL.
