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).
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).
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.
Amgen and Allergan said the FDA Oncologic Drugs Advisory Committee will review data supporting the Biologics License Application for ABP 215, a biosimilar candidate to Avastin (bevacizumab), an agent sponsored by Genentech, a unit of Roche.
Hitachi Healthcare Americas Corp. and MD Anderson Cancer Center announced an agreement to collaborate on a randomized clinical trial comparing the outcomes and side-effects of intensity-modulated proton beam therapy versus intensity-modulated photon therapy for the treatment of oropharyngeal cancer of the head and neck.
FDA approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, as detected by an FDA-approved test.
Advaxis, Inc. and Bristol-Myers Squibb announced a clinical development collaboration to evaluate ADXS-DUAL, an investigational immunotherapy targeting HPV-associated cancers, and Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment option for women with metastatic cervical cancer.
The Johns Hopkins University and Eisai Inc. have extended their drug discovery collaboration through a licensing agreement.
FDA granted regular approval to Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
In an unprecedented, fast-tracked review, FDA granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature.
