Aveo: FDA refuses to approve cancer drug tivozanib for advanced renal cell carcinoma

Aveo Pharmaceuticals Inc. (AVEO) said the U.S. Food and Drug Administration rejected its new drug application for tivozanib as a treatment for advanced renal cell carcinoma, citing inconsistent survival results.

• The company had said last week it expected the rejection. Aveo and partner Astellas Pharma Inc. (ALPMY, 4503.TO) said it would refocus the clinical development of tivozanib in colorectal and breast cancer, as well as advancing key pipeline and preclinical assets.
• Aveo, a developer of cancer therapies, said the FDA's complete response letter stated inconsistent progression-free survival and overall survival results and imbalance in post-study treatments made the TIVO-1 results uninterpretable and inconclusive regarding the risk-benefit assessment necessary for drug approval.
• Aveo also said the agency recommended it conduct an additional clinical study to support approval of tivozanib for advanced RCC.
• However, Aveo has previously said it didn't expect to pursue further development for that use at this time.

NEW YORK (AP) — Aveo Oncology said Monday that the Food and Drug Administration has refused to approve its cancer drug tivozanib, saying the clinical trial data supporting the drug was not clear.

Aveo, whose formal name is Aveo Pharmaceuticals Inc., is seeking approval for tivozanib as a treatment for advanced renal cell carcinoma, the most common type of kidney cancer.

The company said the FDA recommended it run a new clinical trial of tivozanib because it was not able to draw meaningful conclusions from a late-stage trial. That's because of inconsistent survival data and differences in the kinds of therapies patients received after treatment in the study was complete.

In early May an FDA advisory panel said tivozanib shouldn't be approved because the benefits of the pill didn't justify its risks. Later Aveo's partner Astellas Pharma decided not to file for marketing approval of the drug in Europe and said it wouldn't fund any more studies of tivozanib as a treatment for renal cell carcinoma.

Aveo said it is evaluating the effects of Astellas' decision. The Cambridge, Mass., company does not have any approved products and tivozanib is its most advanced experimental drug.

Aveo Pharmaceuticals shares rose 19 cents, or 8.1%, to $2.53 on trading Monday. The stock has lost almost 70% of its value since April 29.

After a recent financing, Aveo said it had $192 million in cash and cash equivalents at the end of the first quarter.

Stifel Nicolaus analyst Brian Klein said in a telephone interview that the company will keep depleting its cash as long as it continues operations. Klein said last month that Astellas' decision was the end of the road for tivozanib.