New FDA approved late-line-indication treatment | ZEJULA
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ZEJULA Is Now FDA Approved to Treat Eligible Women With Advanced Ovarian Cancer1

ZEJULA is FDA approved as a treatment for women who have had at least 3 prior chemotherapy regimens.

A certain “BRCA” gene mutation 2-5


A positive laboratory test, and whose cancer was in response to treatment with

platinum-based chemotherapy, and who have progressed more than 6 months after the last treatment.6-9

ZEJULA is FDA approved as a treatment for women who have had at least 3 prior chemotherapy regimens.

 

A certain “BRCA” gene mutation 2-5

 

 

A positive laboratory test, and whose cancer was in response to treatment with

platinum-based chemotherapy, and who have progressed more than 6 months after the last treatment.6-9

Your healthcare provider will perform a test to make sure that ZEJULA is right for you.1

The study was designed to measure how well women living with advanced ovarian cancer responded to treatment with ZEJULA. The response to ZEJULA treatment was tested in

HRD-positive women, which included women who were BRCA-positive or those who tested positive for a laboratory test and had a

response to platinum-based chemotherapy.1,10,11


Half of women who responded saw a duration of response of greater than 8 months while taking ZEJULA1

Half of women who responded saw a duration of response of greater than 8 months while taking ZEJULA.
Half of women who responded saw a duration of response of greater than 8 months while taking ZEJULA.

The duration of response is the time from the cancer responding to the treatment until the cancer progresses.12

24% of women responded to ZEJULA and had tumors that reduced in size1

24% of women responded to ZEJULA and had tumors that reduced in size.

A response shows if a patient had a reduction in their tumors while on treatment. If some, but not all, of the cancer disappears, it is a partial response. If there are no remaining clinical signs of cancer, it is considered a complete response, although this does not always mean that the cancer has been cured.13,14

     

The safety profile of ZEJULA for the treatment of advanced ovarian cancer was consistent with another clinical trial that studied ZEJULA.1 Please see full Prescribing Information and Important Safety Information below to learn more.

The safety profile of ZEJULA for the treatment of advanced ovarian cancer was consistent with another clinical trial that studied ZEJULA.1 Please see full Prescribing Information and Important Safety Information below to learn more.

References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc.; October 2019. 2. NCI Dictionary of Cancer Terms: BRCA. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/search?contains=false&q=brca. Accessed August 12, 2019. 3. BRCA mutations: cancer risk and genetic testing. National Cancer Institute website. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-factsheet. Accessed August 12, 2019. 4. NCI Dictionary of Cancer Terms: germline mutation. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/germline-mutation. Accessed October 28, 2019. 5. NCI Dictionary of Cancer Terms: somatic mutation. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation. Accessed October 28, 2019. 6. Frey MK et al. Gynecol Oncol Res Pract. 2017;4:4. doi: 10.1186s40661-017-0039-8. 7. Konstantinopoulos PA et al. Cancer Discov. 2015;5(11):1137-1154. 8. Chemotherapy. Ovarian Cancer Research Fund Alliance. https://ocrfa.org/patients/about-ovarian-cancer/treatment/chemotherapy. August 12, 2019. 9. NCI Dictionary of Cancer Terms: Platinum. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/platinum. Accessed August 12, 2019. 10. Anemia. National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health-topics/anemia. Accessed October 31, 2019. 11. NCI Dictionary of Cancer Terms: Hemoglobin. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hemoglobin. Accessed October 31, 2019. 12. FDA. Clinical trial endpoints for the approval of cancer drugs and biologics. https://www.fda.gov/media/71195/download. Accessed August 12, 2019. 13. NCI Dictionary of Cancer Terms: Remission. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/remission. Accessed August 12, 2019. 14. NCI Dictionary of Cancer Terms: Response. National Cancer Institute website. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/response. Accessed August 12, 2019.

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