FDA Oncology Updates

Days after FDA staff reviewers expressed concerns about the "benefit-to-risk" ratio of Votrient (pazopanib) in renal cell cancer, an expert advisory panel unanimously recommended FDA approval for the drug to treat patients with renal cell carcinoma, noting a lack of evidence that the drug was responsible for 3 patient fatalities resulting from liver failure. The FDA’s final decision is due October 19.

FDA has approved OVA1, an adjunctive laboratory test that measures levels of 5 proteins known to change in response to ovarian cancer. Using an algorithm, OVA1 combines the test results and ranks them from 0 to 10, with 0 indicating a benign mass and 10 suggesting a malignant one. Results can help determine the appropriate type of surgery or specialist. The diagnostic test was developed by Johns Hopkins University researchers and Vermillion, Inc., which filed for Chapter 11 bankruptcy in April. Vermillion’s partner, Quest Diagnostics Inc., has exclusive 3-year rights to offer OVA1 to laboratories.

Allos Therapeutics received accelerated FDA approval for Fotolyn (pralatrexate injection), a drug used to treat relapsed or resistant peripheral T-cell lymphoma. It is the first drug approved for this less common type of non-Hodgkin’s lymphoma. Allos expects to begin marketing Fotolyn in October 2009. Accelerated approval means the company must conduct additional studies to confirm the benefit of Fotolyn in this patient population.

Oncolytics Biotech Inc in Canada received a green light from the FDA to initiate a phase 3 trial for Reolysin, an intravenously administered formulation of the reovirus, in patients with head and neck cancer. With the assistance of the FDA, the company will develop trials comparing the effectiveness of Reolysin combined with paclitaxel (Taxol) and carboplatin versus chemotherapy alone. Prior studies found that Reolysin replicates successfully in tumor cells with an activated Ras pathway, leading to apoptosis and may train the immune system to recognize and kill tumor cells.

An FDA advisory committee voted 7 to 0 (with one abstention) to recommend expanding indications for Gardasil to include males aged 9 to 26 years. As well as genital warts, HPV can cause penile and anal cancers in men. It has also been linked to mouth and throat cancers in both sexes. Data presented to the FDA showed it was 89% effective in preventing genital warts, the indication applied for, and no serious adverse effects were observed. Experts such as Professor Jack Cuzick at the Wolfson Institute of Preventive Medicine say developing herd immunity to HPV will require vaccinating males and females.

The FDA has declined to approve an expanded indication for Fusilev (levoleucovorin) as a treatment for metastatic colon cancer, saying it did not demonstrate noninferiority to leucovorin. The FDA has agreed to meet with Spectrum Pharmaceuticals to discuss the decision.