On September 14, 2021 PharmaMar (MSE:PHM) reported that its licensing partner, Specialised Therapeutics Asia, Pte. Ltd. (STA) has received provisional marketing approval for Zepzelca (lurbinectedin) by the Australian Therapeutic Goods Administration (TGA), for the treatment of patients with metastatic Small Cell Lung Cancer (SCLC), that have progressed on or after prior platinum-containing therapy (Press release, PharmaMar, SEP 14, 2021, View Source [SID1234596668]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This means patients who have progressed after other existing treatment options will now be able to access another line of therapy. Lurbinectedin is the first new therapy approved by the TGA to treat second-line SCLC in more than two decades.

Australian lung cancer oncologist Professor Paul Mitchell from the Olivia NewtonJohn Cancer and Wellness and Research Centre at the Austin Hospital in Melbourne, Australia, said SCLC was particularly aggressive and more than two-thirds of patients were diagnosed with extensive stage disease. He said fewer than 5% of these
patients currently survived more than five years post diagnosis.

"The new availability of lurbinectedin will be welcomed by patients, families and the medical community, as we strive to improve patient outcomes for this disease," Professor Mitchell said. "With this approval, we now have another option for patients who have progressed after prior platinum-based treatments. This provides an opportunity for them to continue treatment and potentially, improve outcomes."

The TGA approval of lurbinectedin has been granted under a provisional regulatory pathway. The US Food and Drug Administration (FDA) and Australia’s TGA collaborated via ‘Project Orbis’ to accelerate availability to Australian patients.

Lurbinectedin’s approval is based on clinical data from an open-label, multi-center, single-arm phase II study in 105 adult patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.

The data, which appeared in The Lancet Oncology May 2020 issue, demonstrated that in patients with Relapsed SCLC, Lurbinectedin provided an Overall Response Rate (ORR) of 35% and a median duration of response of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC).

The provisional approval is the subject of a further confirmatory study in more than 700 patients with 2nd line SCLC including some Australian sites. This study is expected to be completed in 2025.

Lurbinectedin is being made available in Australia by the independent pharmaceutical Company, STA, under an exclusive license from international partner, PharmaMar.

José María Fernández, Ph.D., President of PharmaMar said the Company was delighted Australian patients would now be provided access to lurbinectedin. "We are pleased to bring a new treatment choice to relapsed SCLC patients. The accelerated approval of lurbinectedin underscores its potential to fill an unmet need in this oftenoverlooked SCLC community." And added: "We are very thankful that the TGA has been the first regulatory agency to authorize three compounds from PharmaMar."

STA Chief Executive Officer, Carlo Montagner said the approval of lurbinectedin would potentially make a difference for around 400 Australian patients annually who had run out of treatment options. "We are delighted to be able to provide a new therapy option for patients with this difficult to treat cancer," he said. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Our mission has always been to provide therapies in area where there is an unmet need and SCLC is certainly one of these areas. We look forward to making a difference for these
patients and their families."

Lurbinectedin is currently available in Australia via a Special Access Program. Commercial supplies of lurbinectedin in Australia will commence early 2022.