The FDA has decided to postpone the approval for Genesense (oblimersen sodium) due to the lack of adequate data available for the drug. The drug is used in relapsed or refractory chronic lymphocytic leukemia. The Center for Drug Evaluation and Research (CDER) and the FDA agreed that the drug achieved the primary endpoint in the pivotal trial, drug maker Genta said. CDER has asked the company to come up with confirmatory evidence for the drug.

Oncothyreon has filed an INDA with the FDA for PX-866, a small molecule phosphatidylinositol-3-kinase (PI-3-kinase) inhibitor for the treatment of advanced cancers. The compound has been shown to have good single agent in vivo antitumor activity and works well in combination with other agents in a number of human tumor models, the company said. Following FDA review, the company plans to initiate a Phase I clinical trial.

Data presented by Celldex Therapeutics, a wholly-owned subsidiary of AVANT Immunotherapeutics, from its Phase 2 ACT II study in glioblastoma multiforme (GBM) indicated that temozolomide, the standard chemotherapy agent for this disease, may potentiate the effect of AVANT’s vaccine candidate, CDX-110. All patients vaccinated with CDX-110 in the Phase 2a ACT II extension study showed a tumor-specific immune response, a significant improvement over previous vaccines and over CDX-110 alone.

Novartis Inc has initiated the Phase III trial for its non-small cell lung cancer drug, ASA404, designed to selectively reduce blood supply to tumors. The randomized, double-blind, placebo-controlled, multicenter study, named ATTRACT-1, is designed to evaluate ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic non-small cell lung cancer.

Swiss company Novartis AG has reported that an independent data monitoring committee stopped a major trial of an investigational drug after interim results showed significantly better survival rates in kidney-cancer patients taking the therapy.Novartis was in Phase III of clinical trials, but the independent committee stopped the trial, involving some 400 patients in a dozen countries, because the study met its primary endpoint. Researchers say the targeted therapy could have promise for people with late-stage renal-cell cancer. Researchers are also evaluating the drug’s use in neuroendocrine tumors, lymphoma and other cancers.

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