The Diplomat
Spanish pharmaceutical company PharmaMar’s Zepzelca (lurbinectedin) for the treatment of lung cancer patients has received provisional marketing approval from Australia’s Therapeutic Goods Administration (TGA).
According to the company, its local partner, Specialised Therapeutics Asia, Pte. (STA), has received provisional approval for lurbinectedin based on clinical data from a mid-2020 study of the drug, which is used in patients with metastatic small-cell lung cancer in whom other treatments such as chemotherapy have not worked.
The provisional approval is subject to a new confirmatory study in more than 700 patients with small-cell lung cancer. This study is expected to be completed in 2025. Treatment with lurbinectedin is currently available in Australia through a Special Access Program, thanks to the independent pharmaceutical company STA, and under exclusive license from PharmaMar. The start of its commercial supply in the country will commence in early 2022.
“We are pleased to bring a new treatment option to patients with recurrent small-cell lung cancer,” said Pharmamar CEO José María Fernández. “The accelerated approval of lurbinectedin underscores its potential to meet an unmet need in this often-overlooked small-cell lung cancer community,” he continued. “We are very grateful that the TGA was the first regulatory agency to authorize three Pharmamar compounds,” he added, referring to Aplidin, approved in 2018, and Yondelis, authorized last April, as reported by the Spain-Australia Council Foundation.
For his part, Australian oncologist Paul Mitchell, of the Olivia Newton-John Cancer and Wellness Centre in Melbourne, said that “the new availability of lurbinectedin will be welcomed by patients, families and the medical community.” “With this approval, we now have another option for patients who have progressed after previous platinum-based treatments. This gives them the opportunity to continue treatment and potentially improve outcomes,” he added.
For STA CEO Carlo Montagner, the approval of lurbinectedin will be able to make a difference for some 400 Australian patients who had been left without treatment options. “We are delighted to be able to offer a new therapeutic option to patients with this difficult-to-treat cancer,” he said.
