publication date: Dec. 18, 2015

FDA Approves Bendeka Injection 


FDA approved Bendeka (bendamustine hydrochloride) injection, a 10-minute infusion formulation of bendamustine.

Bendeka is approved for the treatment of patients with chronic lymphocytic leukemia and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy relative to first line CLL therapies other than chlorambucil has not been established.

Bendeka is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. Bendeka is also contraindicated in patients with a known hypersensitivity to polyethylene glycol 400, propylene glycol, or monothioglycerol.

Bendamustine hydrochloridecaused severe myelosuppression in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions.

Teva Pharmaceuticals, the sponsor, expects to make Bendeka available to patients in the first quarter of 2016. Bendeka was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.


Stem Cell Theranostics and CapellaBio established a cardio-oncology collaboration to discover novel drug therapies to prevent cardiotoxicity associated with various oncology drugs.

By combining CapellaBio’s SMarTR computational analysis platform with SCT’s iPSC-derived cardiomyocyte discovery platform, advanced drug leads have been identified in the first of a series of programs.

The first collaborative program is focused on discovering cardioprotective drugs to prevent anthracycline-induced cardiotoxicity. There is currently only one FDA-approved agent, Dexrazoxane, but this has limited indication approval and has not been widely used due to concerns that it may interfere with the anti-tumor activity of anthracyclines. Novel cardioprotectants with improved efficacy and safety profiles that could be used across multiple indications would offer significant clinical benefit.


Amgen entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia (denosumab), XGEVA (denosumab) and Vectibix (panitumumab) in 48 countries in Asia, South America, Europe, Australia and other regions.

GSK has held select regional rights to Prolia and XGEVA since 2009 and to Vectibix since 2010 under license from Amgen. In 2014, GSK generated approximately $111 million in combined sales from these licenses. Amgen will make undisclosed milestone payments to GSK on signing and on the successful transition of the products back to Amgen. Amgen will book all product sales following this transition.

Amgen will work closely with GSK to enable a seamless transition for customers and patients. GSK will continue to hold the license and sell and distribute the products for an interim transition period that will vary by country. The majority of markets are planned to be transitioned back to Amgen within a 12-month period.

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