Zepzulca (lurbinectedin) is a new oncology therapy developed by PharmaMar and Jazz Pharmaceuticals
… A novel oncology therapy for lung cancer patients …

Lung Cancer Therapy Zepzelca (lurbinectedin) Earns FDA Approval

Zepzelca is a novel alkylating drug therapy developed by PharmaMar and marketed by Jazz Pharmaceuticals


John G. Baresky

The FDA has approved Zepzelca (PM1183) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca is being developed and commercialized through a collaboration between Jazz Pharmaceuticals (NASDAQ: JAZZ) and PharmaMar (MSE: PHM).

The drug was cleared for use through the FDA’s accelerated approval process based on its overall response rate (ORR) and duration of response; an additional confirmatory trial will be completed to assure its efficacy.

Zepelca is an injectable pharmaceutical oncology therapy

Zepzelca is administered via IV infusion and available only by prescription. The drug is used to treat SCLC in adult patients that have had their cancer metastasize (spread) to other parts of the body and who have been treated with chemotherapy that contains platinum that has not been effective or is losing its ability to effectively treat the patients.

Lung cancer is a leading cause of illness and fatalities in the United States

Lung cancer ranks in the top three of the most frequently diagnosed cancers as well as causes of death from cancer. Overall, cancer is the second leading cause of death in the United States (heart disease is number one).

About one of every four deaths in the United States is cancer-related. Oncologists, pulmonologists and other medical professionals treating lung cancer patients will welcome Zepelca as an additional therapeutic option.

Alkylating chemotherapy products are widely used in cancer treatment

The new pharmaceutical product is an alkylating agent that binds guanine residues within DNA. Alkylating therapies prevent cell-reproduction and perform in all phases of the cell cycle by impacting the activity of DNA binding proteins (including some transcription factors) and DNA repair pathways.

They are used to treat many different cancers, including breast, lung and ovary plus leukemia, lymphoma, Hodgkin disease, multiple myeloma and sarcoma.

Zepzelca will require a precise market access strategy in a highly competitive oncology sector

Zepzelca is specifically intended and approved for the treatment of SCLC; it has not been approved for use in the treatment of other forms of cancer. Its market access strategy value proposition will need to account for care and cost advantages that distinguish it from more than 15 other therapies that are used in treating small cell lung cancer.

Jazz Pharmaceuticals and PharmaMar joined forces to propel Zepzelca through development, approval and launch processes

Founded in 2005, Jazz Pharmaceuticals, headquartered in Dublin, Ireland, generated over $2 billion in sales during 2019. It licensed Zepzelca from Madrid, Spain-based PharmaMar. The licensing arrangement requires Jazz to pay PharmaMar $200 million for U.S. rights to Zepzelca plus $250 million in milestone payments based on certain drug development and regulatory approval goals.

PharmaMar can earn up to $550 million in additional payments from Jazz based on the achievement of sales and other commercialization objectives. PharmaMar was founded in 1986 and generates roughly $100 million in annual sales.

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