Drugs

BMS, Daiichi Sharing Breast Cancer Treatment Trial

Bristol-Myers Squibb and Daiichi Sankyo say they are collaborating on a clinical trial to evaluate the combination of BMS’ immunotherapy Opdivo (nivolumab) and Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and urothelial cancers. The multicenter Phase 1b open-label study will look at both dose escalation and dose expansion.

A statement says the study is expected to begin enrollment in the first quarter of 2018 in the U.S. and Europe. Under the agreement, Daiichi Sankyo will be the sponsor conducting the trial.

Daiichi says its DS-8201 is in Phase 1 clinical development for HER2-positive advanced or metastatic breast cancer and gastric cancer, HER2-low expressing breast cancer, and other HER2-expressing solid cancers. FDA granted it fast track designation for treating HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including adotrastusumab emtansine(Genentech’s Kadcyla). It has not been approved for any indication in any country.

Opdivo’s global development program is said to include a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. It is currently approved in more than 60 countries, including the U.S., the European Union, and Japan. In 10/2015, BMS’ Opdivo/Yervoy combination regimen was the first immune-oncology combination to receive regulatory approval for treating metastatic melanoma. It is currently approved in more than 50 countries, including the U.S. and the European Union.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome