New Data for Zepzelca™ (lurbinectedin) to be Presented at IASLC 2020 North America Conference on Lung Cancer
DUBLIN, Oct. 14, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and its partner PharmaMar (MSE: PHM) today announced they will present new data for Zepzelca™ (lurbinectedin) in small cell lung cancer (SCLC) at the International Association for the Study of Lung Cancer (IASLC) 2020 North America Conference on Lung Cancer, which will be held October 16-17, 2020 as a virtual event.
"Jazz is committed to improving outcomes for patients with SCLC where there continues to be a high unmet need despite research and treatment advancements," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "At this year's IASLC virtual meeting, we look forward to presenting, along with our partner PharmaMar, data on lurbinectedin, our newest oncology medicine to be approved by the U.S. FDA."
Highlights at the 2020 North America Conference on Lung Cancer include:
The IASLC 2020 North America Conference on Lung Cancer presentations will be presented on October 16 from 5 – 6 p.m. CDT at https://naclc2020.iaslc.org/.
A full list of presentations follows below:
Zepzelca is approved in the U.S. for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. Zepzelca was approved by the U.S. Food and Drug Administration (FDA) under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1
About Zepzelca™ (lurbinectedin)
Zepzelca for injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.
As previously announced in December 2019, PharmaMar and Jazz entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to Zepzelca.
Important Safety Information
Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.
What should I avoid while using ZEPZELCA?
Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA.
ZEPZELCA can cause serious side effects, including:
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA.
The most common side effects of ZEPZELCA include:
These are not all of the possible side effects of ZEPZELCA.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.
More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here.
ZEPZELCA is a trademark of PharmaMar, S.A. used by Jazz Pharmaceuticals under license.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
About Jazz Pharmaceuticals
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SOURCE Jazz Pharmaceuticals plc
Company Codes: NASDAQ-NMS:JAZZ, India:PHM