Inex/Enzon’s Marqibo Will Get Oncologic Advisory Cmte. Review Dec. 1, Firms Say
This article was originally published in The Pink Sheet Daily
Executive Summary
The sponsors are seeking a monotherapy indication for treatment of relapsed aggressive non-Hodgkin’s lymphoma in patients previously treated with at least two combination chemotherapy regimens. The NDA's user fee date is Jan. 15.
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Berlex is seeking an indication for the bisphosphonate clodronate as adjuvant therapy of bone metastases in Stage II/III breast cancer patients. Dec. 1 review date confirmed for Inex/Enzon’s Marqibo (liposomal vincristine) and Ilex’ Clolar (clofarabine).
Berlex Bonefos For Breast Cancer Bone Metastases Set For Cmte. Review Dec. 2
Berlex is seeking an indication for the bisphosphonate clodronate as adjuvant therapy of bone metastases in Stage II/III breast cancer patients. Dec. 1 review date confirmed for Inex/Enzon’s Marqibo (liposomal vincristine) and Ilex’ Clolar (clofarabine).
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