Eli Lilly: FDA grants priority review on breast cancer drug.
(CercleFinance.com) - Eli Lilly said on Monday that the Food and Drug Administration has agreed to a priority review of its experimental advanced breast cancer drug abemaciclib.
The application includes submission for monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease.
The FDA's decision also includes abemaciclib, in combination with fulvestrant, for women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy.
In a press release, Eli Lilly says it is anticipating an approval from the FDA in the first quarter of 2018.
In addition, the pharmaceutical giant intends to submit abemaciclib to European regulators in the third quarter of 2017, followed by Japanese regulators before the end of the year.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The application includes submission for monotherapy for patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who had prior endocrine therapy and chemotherapy for metastatic disease.
The FDA's decision also includes abemaciclib, in combination with fulvestrant, for women with HR+, HER2- advanced breast cancer who had disease progression following endocrine therapy.
In a press release, Eli Lilly says it is anticipating an approval from the FDA in the first quarter of 2018.
In addition, the pharmaceutical giant intends to submit abemaciclib to European regulators in the third quarter of 2017, followed by Japanese regulators before the end of the year.
Copyright (c) 2017 CercleFinance.com. All rights reserved.