23 September 2021 | Thursday | News
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The drug ZEPZELCA (lurbinectedin) has been provisionally approved by Singapore's 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 failed other existing treatment options will now have a further therapeutic option.
ZEPZELCA is the first new therapy approved by the HSA to treat second-line SCLC in more than two decades, and is the third oncology drug in Specialised Therapeutics (ST) portfolio to receive HSA approval.
The Singapore approval follows on from approvals by the US Food and Drug Administration (FDA) decision, 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. He said fewer than 5% of these patients currently survived more than five years post diagnosis.[4,5]
"The new availability of ZEPZELCA 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 ZEPZELCA has been granted following collaboration with the US FDA via the 'Project Orbis' initiative, due to the high unmet clinical need in SCLC. It is based on monotherapy clinical data from an open-label, multi-centre, single-arm study in 105 adult platinum-sensitive and platinum-resistant 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, ZEPZELCA provided an 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 2L SCLC. This study is expected to be completed in 2025.
ZEPZELCA is being made available in Singapore by independent pharmaceutical company Specialised Therapeutics under exclusive license from its international 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.[7,8]
"We are delighted to be able to provide a new therapy 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.
"We expect that this therapy may now be an option for up to 100 Singapore patients every year and look forward to making a difference for these patients and their families."
PharmaMar president José María Fernández Sousa-Faro, PhD, said the company was delighted South-East Asian patients would now be provided access to ZEPZELCA.
"We are pleased to bring a new treatment choice to relapsed SCLC patients. "The accelerated approval of ZEPZELCA underscores its potential to fill an unmet need in this often-overlooked SCLC community."
ZEPZELCA has been available in Singapore via an Early Access Program since July 2020.