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Lotus Announces Zepzelca® (lurbinectedin) Has Acquired TFDA Accelerated Approval for the Treatment of Metastatic Small Cell Lung Cancer

11 July 2023
  • ZEPZELCA is Lotus’ first licensed new chemical entity (NCE) oncology treatment to gain approval.
  • The approval is granted on an accelerated approval basis; the accelerated approval designation from the TFDA is designed to facilitate the development of medicines that may fill critical unmet medical needs.
  • ZEPZELCA is the first new treatment for second line metastatic small cell lung cancer to be approved in over a decade.

Taipei, Taiwan, July 11th, 2023 -- Lotus Pharmaceutical (1795:TT; “Lotus” or “the Company”), a multinational pharmaceutical company, has announced that it has received accelerated approval from Taiwan Food and Drug Administration (TFDA) for ZEPZELCA (lurbinectedin), which is indicated for the treatment of adult metastatic small cell lung cancer (SCLC) patients with disease progression on or after platinum-based chemotherapy. The approval of ZEPZELCA marks a significant milestone for the company, marking Lotus’ first licensed NCE oncology therapy to receive approval.  The approval is based on the overall response rate and duration of response demonstrated in open-label monotherapy clinical trial. The TFDA grants accelerated approval designation in order to facilitate the development and expedite the review of applications for medicines to treat serious conditions that may fill critical unmet medical needs.

In late 2021, Lotus signed an exclusive licensing and commercialization agreement with PharmaMar for ZEPZELCA in Taiwan. ZEPZELCA is already commercialized in markets outside of Taiwan, including major markets such as the US, Europe, Singapore, and South Korea.

Small cell lung cancer, representing 15% of all lung cancer cases, is the most aggressive type of lung cancer with a notably low survival rate. The significant recurrence rate creates a considerable challenge for existing clinical approaches to this disease, calling for inventive solutions urgently.  ZEPZELCA is the first new treatment option for second line metastatic small cell lung cancer in over a decade.

Petar Vazharov, Lotus' Chief Executive Officer, said: "We are delighted to announce the accelerated approval of ZEPZELCA, which represents a significant validation of Lotus' dedication to providing innovative treatments to patients suffering from cancer.  As part of our development program last year, we are proud to have initiated the Named Patient Program (NPP), a compassionate use initiative, in Taiwan, granting qualified local patients’ immediate access to this medication. This approval further expands access to this medicine for all patients in need. The approval of ZEPZELCA, along with our recent acquisition of Alimta® (Pemetrexed), combined with several other products from our own proprietary R&D center has greatly enhanced Lotus’ standing in the treatment of lung cancer, a leading cause of death in Taiwan."


About Lotus

Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with global presence, focused on commercializing novel and generic pharmaceuticals, offering patients better, safer and more accessible medicines. The Company has a recognized best-in-class R&D and manufacturing platform in Asia and has established partnerships in nearly every global market including the U.S., Europe, Japan, China, and Brazil. Lotus runs over 100 strategically selected pharmaceutical projects in development and registrations across Asia and the US, with over 250 commercial products. The Company invests in diversified best portfolio consisting of high-barrier oncology, complex generics as well as 505(b)2 and NCE via internal R&D investment and licensing-in partnership, and also strengthens its portfolio competitiveness by adding biosimilar products with support from strategic partners. Its industry-leading infrastructure certified by most of the advanced regulatory authorities around the world, including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.


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