publication date: Jun. 9, 2017

Drugs and Targets

BMS, Novartis announce collaboration focused on metastatic colorectal cancer

Bristol-Myers Squibb and Novartis announced a clinical research collaboration to investigate the safety, tolerability, and efficacy of Mekinist (trametinib) in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a potential treatment option for metastatic colorectal cancer in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair (MSS mCRC pMMR).

The study, which will be conducted by BMS, is aimed at establishing recommended dose regimens and the preliminary anti-tumor activity of the combination therapies. Both BMS and Novartis will evaluate the results to determine optimal approaches and potential clinical development of these combinations.

Mekinist is a kinase inhibitor indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

 

Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients

FDA approved the Ventana ALK CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with the Novartis drug Zykadia (ceritinib).

The Ventana ALK (D5F3) Assay is the only immunohistochemistry test approved by the FDA as a companion diagnostic for ZYKADIA.

The assay is sponsored by Roche.

The Ventana ALK CDx Assay is available for use on BenchMark IHC/ISH instruments.

 

FDA Approves Hologic’s Genius 3D Mammography Exam

Hologic Inc. said the Genius 3D Mammography exam has become the only mammogram that is FDA-approved as superior to standard 2D mammography for routine breast cancer screening of women with dense breasts.

The Genius exam has been commercially available in the U.S. since 2011, and the newly approved physician labeling is based on clinical studies proving that the … Continue reading BMS, Novartis announce collaboration focused on metastatic colorectal cancer

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