- Zepzelca (Lurbinectedin) gets TGA (Therapeutic Goods Administration) approval under a provisional regulatory pathway.
- Zepzelca (Lurbinectedin) becomes the first new treatment option for patients with second-line metastatic Small Cell Lung Cancer (SCLC) in more than a decade.
- Important approval also for patients who have previously received platinum-based chemotherapy.
Zepzelca (Lurbinectedin) becomes the new therapy for Australian patients with second-line metastatic Small Cell Lung Cancer (SCLC). It is also approved for patients who have received therapy with platinum-based chemotherapy previously. Such access to a new treatment may lead to potential improvements in outcomes.
The therapy has been approved by the TGA (Therapeutic Goods Administration) in Australia. This means lung cancer patients who have gone through other treatments (that have failed) can be treated using another line of cancer therapy.
The approval of Zepzelca (Lurbinectedin) by the TGA has been granted under a provisional regulatory pathway. Australia’s TGA and US FDA (Food and Drug Administration) have further collaborated to accelerate the availability of Lurbinectedin via ‘Project Orbis’.
Besides that, the approval is based on a multi-center, single-arm, open-label phase II clinical study in 105 Small Cell Lung Cancer patients (adults) whose disease has progressed after receiving platinum-based chemotherapy. It provided an average duration of response of 5.3 months and an ORR (overall response rate) of 35% as per the investigator’s assessment.
Furthermore, ZEPZELCA (Lurbinectedin) is being made available under exclusive license from the international partner (PharmaMar) of the independent pharmaceutical Company, i.e., Specialized Therapeutics.
About Zepzelca (Lurbinectedin)
Zepzelca is an alkylating ********** that belongs to the category of chemotherapeutic *****. It works by binding guanine residues within DNA. This triggers a couple of events affecting the DNA activity and repair pathways. As a result, disruption of the cell cycle occurs and leads to cell death.
Zepzelca 4 mg is a prescription drug that is used for the treatment of patients with second-line metastatic Small Cell Lung Cancer (SCLC). Additional studies in the future will investigate its other benefits later.
About Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer is a condition characterized by the formation of malignant (cancer) cells in the lung tissues. Mainly, it is known as fast-growing lung cancer. Its major cause is smoking. Apart from that, the two stages of SCLC are extensive-stage and limited-stage. Usually, the condition is diagnosed near the breathing tubes or bronchi and grows rapidly. This disease represents more than 10% of all lung cancers.