FDA seeks more clinical evidence on Sunesis Pharma cancer drug

FDA seeks more clinical evidence on Sunesis Pharma cancer drug

By Anjali Rao Koppala

(Reuters) – Sunesis Pharmaceuticals Inc said the U.S. Food & Drug Administration called for more clinical evidence before considering approval for its cancer drug, sending the company's shares down 60 percent in after-market trading.

The drug, vosaroxin, failed a late-stage trial in October as it did not significantly improve the overall survival of patients compared with a placebo.

p> The FDA wanted the additional evidence before Sunesis files its marketing application for the drug, the company said in a statement on Thursday.

The European Medicines Agency (EMA) however, gave the company the nod to submit a marketing application for vosaroxin, Sunesis said.

"The EMA has a history of taking in the whole picture while the FDA historically sticks to statistics," RBC Capital Markets analyst Adnan Butt said.

Butt expects the decision on the European approval to come through by 2016.

Approval in the United States, however, can be delayed by a few years as the company would need to run additional trials, he added.

The company said on a conference call with analysts, that it remained well funded till mid-2016.

The drug is being tested in patients with acute myeloid leukemia (AML), a fast-growing cancer of the blood & bone marrow that usually affects seniors.

Sunesis said it would work to complete its filing as swift as possible in Europe & refine its plan to gain approval in the United States.

Nearly 15,000 people are diagnosed with AML in the United States each year, according to the National Cancer Institute.

Besides the chemotherapy agent cytarabine, AML is currently treated with another standard chemotherapy daunorubicin, & with stem cell transplant.

Sunesis' shares fell to $1.40 in extended trading on Thursday. The stock closed at $3.47 on the Nasdaq.

(Reporting by Anjali Rao Koppala & Amrutha Penumudi in Bengaluru; Editing by Simon Jennings & Andrew Hay)

Food & Drug AdministrationEuropean Medicines Agency

Source: “Reuters”

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