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Australian TGA Agency Approves Drug Zepzelca® (Lurbinectedin) For Cancer Treatment

The Therapeutic Goods Administration Health Agency (TGA) has granted provisional marketing approval for the drug Zepzelca® (Lurbinectedin), indicated for the treatment of adult patients with small cell lung cancer (SCLC). metastatic, called metastatic small cell lung cancer, with disease progression during or after platinum-based chemotherapy1. This means that patients who have received chemotherapy treatment that contains platinum, and it did not work or no longer works, will now be able to access another line of cancer therapy.

Zepzelca® (Lurbinectedin) works in the body to help fight metastatic small cell lung cancer by:

1. Join the DNA.

2. Interfere with the function of cancer cells.

3. Cause cancer cell death.

Zepzelca® (Lurbinectedin) is the first new treatment approved by the TGA to treat second-line small cell lung cancer in more than two decades.

The approval of Zepzelca® (Lurbinectedin) by the TGA Agency has been granted through an interim regulatory route. The US Food and Drug Administration (FDA) and the TGA have collaborated through the "Orbis Project" to accelerate the availability of Zepzelca® (Lurbinectedin) to Australian patients. The provisional health authorizations for marketing, granted by Health Agencies of Countries of High Health Surveillance, allow the scientific community and patients to access new and innovative cancer therapies in a timely manner, and face an important public health problem.

The approval of Zepzelca® (Lurbinectedin) is based on clinical data from a single-arm, multicenter, open-label phase II study in 105 adult patients with small cell lung cancer who had disease progression after treatment. with platinum-based chemotherapy2. The data were published in the May 2020 issue of the specialized journal, The Lancet Oncology2. Complementary to the provisional authorization, a new study is being carried out

Confirmation multicenter clinic in more than 700 second-line small cell lung cancer patients, including some Australian centers. This phase III clinical study is expected to end in 2025.

Australian lung cancer oncologist Professor Paul Mitchell of the Olivia Newton-John Cancer and Wellness Center at Austin Hospital in Melbourne, Australia, stated that small cell lung cancer is particularly aggressive and that more than two thirds of patients are diagnosed in an advanced stage of the disease. He said that currently less than 5% of these patients survive more than five years after diagnosis3,4: "The new availability of the drug Zepzelca® (Lurbinectedin) will be well received by patients, families and the medical community, as we strive for improving outcomes for patients with this disease, "said Professor Mitchell. "With this approval, we now have another option for patients who have progressed from previous platinum-based treatments. This gives them the opportunity to continue treatment and potentially improve outcomes."

Zepzelca® (Lurbinectedin) is a new treatment option for Australian patients with recurrent small cell lung cancer. The accelerated approval of Zepzelca® (Lurbinectedin) highlights its potential to meet an unmet need in this often overlooked small cell lung cancer community. Some 400 Australian patients a year had run out of treatment options. Zepzelca® (Lurbinectedin) is a new therapeutic option for patients with this difficult-to-treat cancer. Although patients may initially respond to traditional chemotherapy, they often experience an aggressive relapse that is historically resistant to treatment. Zepzelca® (Lurbinectedin) is a therapy in areas where there is an unmet need and small cell lung cancer is certainly one of these areas.

Zepzelca® (Lurbinectedin) is currently available in Australia through a Special Access Program.

The commencement of commercial supply of Zepzelca® (Lurbinectedin) in Australia will begin in early 2022.

Zepzelca® (Lurbinectedin) is available in Australia from the pharmaceutical company, Specialized Therapeutics (ST) is an international biopharmaceutical company

independent, under the exclusive license of the Spanish biopharmaceutical company, PharmaMar.

1 Prescribing information for lurbinectedin in Australia.

2 Wheat J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase basket trial. Lancet Oncol. 2020 May; 21 (5): 645–654.

3 PDQ Adult Treatment Editorial Board. Small Cell Lung Cancer Treatment (PDQ®) Health Professional Version. Published online: May 1, 2019. Available at (accessed 8 October 2019)

4 Cancer Council

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