On September 30, 2021 PharmaMar (MSE:PHM) reported that its licensing partner, Jazz Pharmaceuticals plc (Nasdaq: JAZZ), has received conditional approval from Health Canada for ZepzelcaTM (lurbinectedin) for the treatment of adult patients with relapsed stage III or metastatic small cell lung cancer (SCLC), with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, SEP 30, 2021, View Source [SID1234596671]). Lurbinectedin will be available in Canada later this year.
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This new approval of lurbinectedin is based on the same monotherapy clinical data from the open-label, multi-center, single-arm study in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease) that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US. The data, which was published in the May 2020 issue of The Lancet Oncology, showed that in relapsed SCLC, lurbinectedin demonstrated an Objective 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)).
The conditional approval is subject to confirmation in a Phase III study in 2 nd line SCLC, planned to be initiated by the end of 2021.
"We are pleased to bring a new treatment choice to Canadian patients with relapsed SCLC," said José María Fernández, PhD, President of PharmaMar. "Canada is the fifth country to approve lurbinectedin for the treatment of SCLC, following in the footsteps of the United States, the United Arab Emirates and, more recently, Australia and Singapore. We are confident that further approvals will be granted soon in more countries.