Celgene announced that after consultation with the FDA, it will discontinue treatment with Revlimid in the open-label, phase III ORIGIN trial, which enrolled 450 patients in over 100 sites in 26 countries. An imbalance was observed in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil. The FDA placed the ORIGIN study on clinical hold on July 12, with the discontinuation of lenalidomide treatment. All clinical investigators in ongoing chronic lymphocytic leukemia studies using lenalidomide will be officially advised of this action and instructed to inform their patients accordingly, Celgene said. Revlimid is not approved as a treatment for patients with chronic lymphocytic leukemia. Based on an imbalance in deaths, specifically 34 deaths out of 210 patients in the lenalidomide arm compared to 18 deaths out of 211 patients in the chlorambucil arm, FDA placed the study on clinical hold. No specific causality for this imbalance has been identified to date. All other Celgene-sponsored chronic lymphocytic leukemia clinical trials with lenalidomide are continuing in accordance with their respective protocols, the company added.
And the second failure:
Novartis AG (NYSE:NVS; SIX:NOVN) disclosed in its 2Q13 earnings that dovitinib lactate (TKI258) missed the primary endpoint of improving progression-free survival (PFS) vs. Nexavar sorafenib from Bayer AG (Xetra:BAYN) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) in a Phase III trial to treat metastatic renal cell carcinoma (RCC). Novartis could not be reached for details. The open-label, international trial enrolled about 564 patients with metastatic RCC after failure of prior anti-angiogenic therapies. Dovitinib, an oral multitargeted receptor tyrosine kinase inhibitor (TKI), is in Phase II testing to treat endometrial cancer, scirrhous gastric carcinoma, advanced breast cancer, relapsed multiple myeloma (MM) and urothelial cancer.
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