News Feature | February 21, 2014

FDA Gives Topotarget Acceptance To File For Beleodaq

Source: Pharmaceutical Online

By Cyndi Root

Topotarget announced in a press release that the Food and Drug Administration (FDA) has given acceptance to file for Beleodaq. Additionally, the FDA has granted Priority Review for the New Drug Application (NDA). Beleodaq is indicated for   relapsed or refractory peripheral T-cell lymphoma (PTCL). The FDA decision is due in August. Approval triggers a payment of ten million dollars from Spectrum Pharmaceuticals, Inc. to Topotarget along with one million shares. Anders Vadsholt, CEO of Topotarget, said, “This is a significant milestone for Beleodaq for the treatment of R/R PTCL patients. Also, the Priority Review designation underlines our drug’s potential compared to available treatments.”

Peripheral T-Cell Lymphoma

PTCL is a blood cancer whereby the immune system makes lymphocytes that grow indiscriminately. These white blood cells migrate to other parts of the body including organs, blood, bone marrow, and lymph nodes. The cells develop into tumors and PTCL is known for fast growing tumors. PTCLs have subtypes that are treated as separate diseases. Some are rare while others are more common. Treatment usually consists of chemotherapy or a multi-drug protocol. Some patients have relapsed or refractory PTCL; either the cancer comes back or the treatments do not work.


Beleodaq is indicated for relapsed or refractory PTCL. Beleodaq is being studied as a standalone drug or in conjunction with other drugs. It is a pan-HDAC inhibitor with multiple action mechanisms including cell death and cell growth inhibition. Beleodaq’s promise for relapsed or refractory PTCL lies in its success with tumors that have previously been resistant to treatment from other agents like taxanes and topoisomerase II inhibitors.

Spectrum Pharmaceuticals filed the NDA for Beleodaq in December 2013. The FDA is required to respond to the application within 60 days. Then, the agency informs the drug sponsor about the timeline for the review process. Since Beleodaq received Priority Review, the FDA may approve it within six months. If approved, the FDA may require additional studies to find the optimal dose.  

About Topotarget and Spectrum
Topotarget is headquartered in Denmark. It focuses on oncology drugs like Beleodaq.  Spectrum Pharmaceuticals focuses on hematology and oncology. It develops, acquires, and licenses drugs.