good news for cvac

It won't be an easy path to commercialization but results like this from the competition can only help................... I wonder if potential investors in Prima have been waiting for this result prior to taking a position?.........


UPDATE: FDA Panel Rejects Proposed J&J, Zeltia Cancer Drug Yondelis

July 15, 2009: 02:25 PM ET


(Updates with comment from Zeltia Group)

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- A Food and Drug Administration panel Wednesday rejected Yondelis, a proposed cancer drug for women with relapsed ovarian cancer that would be marketed by a unit of Johnson & Johnson (JNJ).

The panel voted 14 to one in the question of whether adding Yondelis to another drug Doxil represented a favorable risk-benefit analysis.

Food and Drug Administration staff reviewers said they saw additional toxicities adding Yondelis to Doxil, which is also marketed by a J&J unit in a study involving patients with relapsed ovarian cancer, and questioned whether a six-week delay in disease progression was worth it, given the side effects.

Yondelis, which was developed by a unit of the Spanish company Zeltia Group ( ZEL.MC), was studied in 672 patients with ovarian cancer who had been previously treated with at least one drug. The study looked at Yondelis in combination with Doxil and Doxil alone. The study showed the median progression-free survival, or the time before the disease worsens, was 5.8 months for patients receiving Yondelis compared to 7.3 months for patients receiving Doxil alone.

Zeltia later Wednesday said it will work together with the FDA to try to solve the problems that made the panel reject the drug.

The FDA said it would ask the panel to discuss whether the results are clinically significant and are "associated with an acceptable benefit risk ratio." The agency said adding Yondelis to Doxil increased the rate of side- effects that included cardiac problems and an increase in liver enzymes that can indicate liver damage.

The agency said it would also ask the panel if the agency should wait for final survival data from the clinical trial before approving the drug.

In documents prepared for Wednesday's meeting, J&J's Ortho Biotech unit said Yondelis offers women a new type of treatment option that attacks cells in a different manner than other chemotherapy drugs currently on the market. The company also noted the drug can be given to women who cannot receive platinum- or taxane-based chemotherapy drugs.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [email protected]

(Ana Garcia in Madrid contributed to this article.)