On November 30, 2021 Jazz Pharmaceuticals plc (NASDAQ: JAZZ) along with partner PharmaMar (MSE: PHM) reported the commercial availability of ZepzelcaTM (lurbinectedin) after receiving conditional approval by Health Canada in September 2021 (Press release, Jazz Pharmaceuticals, NOV 30, 2021, View Source,Health%20Canada%20in%20September%202021%20 [SID1234597678]). Zepzelca is the first new treatment in Canada for adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy in more than a decade.1
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Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death in Canada.2 SCLC is the most aggressive form of lung cancer.3 It represents a significant health burden, with more than 4,000 cases annually across Canada, and accounts for about 13 per cent of all lung cancers. While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that may not respond to treatment.4 The general five-year survival rate for people with SCLC is 7 per cent.5
"This is a significant milestone for people with relapsed small cell lung cancer and further demonstrates Jazz’s commitment to developing life-saving medicines for people with limited options." says Paul Petrelli, general manager, Jazz Pharmaceuticals Canada Inc. "We are proud to introduce this meaningful new treatment to patients in Canada."
The Health Canada conditional approval of Zepzelca was based on overall response rate and duration of response.1 The planned confirmatory study will be initiated later this year.
"Small cell lung cancer is a disease with a particularly poor prognosis. While chemotherapy is highly effective for most patients initially, the vast majority progress within months of completing treatment. Once the cancer starts to regrow, we are very limited in what we can do to manage their condition," says Dr. Rosalyn Juergens from McMaster University, Juravinski Cancer Centre. "Further research is needed in Canada but the addition of Zepzelca to the second line therapy landscape is welcome news for doctors, patients and their families."
"Patients with small cell lung cancer in the second line and their families have been on the sidelines for far too long. The availability of Zepzelca in Canada is a great new option," says Shem Singh, executive director, Lung Cancer Canada. "It gives patients and their families hope – hope for more time, hope for one more family celebration, hope for one more hug – and that’s a very powerful thing. With time being of the essence for small cell lung cancer patients, we call on stakeholders to quickly make this treatment publicly funded for those who can’t wait."
The conditional approval of Zepzelca by Health Canada is based on results from a Phase II open-label, multi-centre, multi-cohort, single-arm study (Study B-005) consisting of 105 SCLC patients who were treated with 3.2 mg/m2 Zepzelca, administered as a 60-minute intravenous infusion repeated every 21 days (one-cycle).1 The data showed that in patients with relapsed SCLC, Zepzelca demonstrated an overall response rate of 35 per cent and a median duration of response of 5.3 months as measured by investigator assessment.1
Zepzelca is indicated for the treatment of adult patients with Stage III or metastatic SCLC who have progressed on or after platinum-containing therapy.1 Zepzelca works by preventing the cancer cells from growing and spreading to other parts in the body. Zepzelca also reduces the ability of other cells to support the growth of the cancer cells. This helps stop the growth of the cancer cells. The recommended Zepzelca dosing is 3.2 mg/m2 by intravenous infusion over 60 minutes repeated every 21 days until disease progression or unacceptable toxicity.
The most common (≥20%) reported adverse events (all grades) were fatigue (77%), nausea (37%), neutropenia (33%), decreased appetite (33%), musculoskeletal pain (31%), dyspnea (31%), constipation (31%), respiratory tract infection (26%), vomiting (22%), diarrhea (20%) and cough (20%).1
For more information, please refer to the product monograph for Zepzelca in Canada located here.
Small cell lung cancer is a fast-growing lung cancer that develops in the tissues of the lungs.6 By the time a person receives a diagnosis, it has typically spread (metastasized) outside of the lungs. This cancer is also more likely than other types of lung cancer to come back after treatment. Small cell lung cancer is sometimes, but not often, called oat cell cancer because the small, oval-shaped cells look like oat grains under a microscope. People with and without a smoking history are all at risk for lung cancer. However, small cell lung cancer almost always develops in people who have a long history of tobacco use.