FDA Updates

OBTNJanuary 2010
Volume 4
Issue 1

Click here to view as PDF.

The FDA has agreed to fast track its review of BSI-201, a PARP inhibitor being studied as a treatment for triple-negative metastatic breast cancer. Women with triple-negative disease have few options, which is why the FDA granted a fast track review to sanofi-aventis, the maker of BSI-201. According to sanofi, preliminary data showed that BSI-201 increased survival by 4.5 months in a phase II trial of women with breast cancer.

The FDA approved a label change for Velcade (bortezomib), allowing Takeda Pharmaceuticals, which manufactures Velcade, to state that it has led to longer survival in patients with multiple myeloma. This was based on data from a clinical trial that found Velcade reduced the risk of death by 35% compared with melphalan and prednisone. Takeda will also be able to reference this claim in marketing the drug.

The struggling pharmaceutical company Adventrx has submitted a New Drug Application to the FDA for ANX-530, a proprietary formulation of the chemotherapy agent vinorelbine (Navelbine). The drug is designed to reduce the vein irritation and blistering commonly associated with the intravenous administration of Navelbine. Adventrx says studies show ANX- 530 is the clinical bioequivalent of Navelbine.

The FDA has granted orphan drug designation to CP- 4126—a lipid-conjugated form of the anti-cancer drug gemcitabine (Gemzar)—for pancreatic cancer. Made by Norwegian company Clavis Pharma, the drug was granted equivalent designation by the European Commission in October 2009.

Neoprobe Corporation has submitted to the FDA an Investigational New Drug Amendment that includes a proposed phase III clinical trial of Neoprobe’s RIGScan CR radiopharmaceutical for patients with colon or rectal cancer. The phase III randomized clinical study will evaluate the ability of RIGScan CR to identify tumor-associated tissue and assess the overall survival of RIGScan CR-treated patients.

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