PharmaMar announces Singapore Health Sciences Authority approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer

PharmaMar (MSE:PHM) has announced today that its licensing partner, Specialised Therapeutics Asia, Pte. Ltd. (STA) has received provisional marketing approval for Zepzelca® (lurbinectedin) by the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) who have progressed after prior platinum-containing chemotherapy. This means, patients who have progressed after front line treatment will now have a further therapeutic option. Lurbinectedin is the first new therapy approved by the HSA to treat second-line SCLC in more than two decades. The Singapore approval follows on from approvals by the US Food and Drug Administration (FDA), as well as the Therapeutic Goods Administration (TGA) in Australia. Lung Cancer Oncologist and past president of Australasian Lung Cancer Trials Group Professor Paul Mitchell from the Olivia Newton-John Cancer and Wellness and Research Centre said SCLC was particularly aggressive and more than two-thirds of patients were diagnosed with extensive stage disease, adding that 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 HSA approval of lurbinectedin has been granted following collaboration with the US FDA via ‘Project Orbis’ initiative, due to the high unmet clinical need in SCLC. It is based on monotherapy clinical data from the open-label, multi-center, single-arm 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 (DoR) of 5.3 months as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC)). Lurbinectedin is being made available in Singapore by an independent pharmaceutical company, Specialised Therapeutics, under exclusive license from its partner PharmaMar. Specialised Therapeutics Chief Executive Officer Mr. Carlo Montagner said lung cancer was the third most common cancer in Singapore, representing more than 22% of all cancer deaths. SCLC represented between 10 – 15% per cent of all lung cancer diagnoses. “We are delighted to be able to provide a new therapeutic option in Singapore 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. PharmaMar president José María Fernández, Ph.D., said the Company was delighted Singaporean 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 often-overlooked SCLC community.” Lurbinectedin has been available in Singapore via an Early Access Program since July 2020.

The release as fetched from its publisher. pharmamar.com ↗