PKC412 (midostaurin) was been granted Priority Review for new drug application for the treatment of acute myeloid leukemia in newly-diagnosed adults with an FMS-like tyrosine kinase-3 mutation, as well as for the treatment of advanced systemic mastocytosi. The premarket approval application for the PKC412 (midostaurin) FLT3 companion diagnostic, developed by Novartis in collaboration with Invivoscribe... […]
MYLAN N.V. and Biocon Ltd. announced submission of Mylan’s biologics license application for MYL-1401O, biosimilar trastuzumab, to the FDA through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the... […]
THE JOHNS HOPKINS UNIVERSITY and Bristol-Myers Squibb Co. announced a five-year collaboration aimed to answer why some patients respond to checkpoint blockers and some do not, and to develop more effective combination immunotherapies. Projects included in the collaboration will span laboratory research on patients’ tumor samples and several early-stage clinical trials led by Johns Hopkins... […]
AMGEN and Janssen Biotech Inc. announced a collaboration to evaluate the combination of Amgen’s Kyprolis (carfilzomib) and Janssen’s Darzalex (daratumumab) in multiple clinical studies in patients with multiple myeloma. Under the agreement, the companies may elect to supply drug only or supply drug and share development costs on a study-by-study basis.The first study initiated as... […]
OPDIVO (nivolumab) received FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.
VENTANA ALK (D5F3) CDx Assay received FDA approval for use on the VENTANA BenchMark ULTRA automated slide stainer. The assay is a companion diagnostic to aid in the identification of ALK-positive lung cancer patients who are eligible for treatment with Pfizer’s FDA-approved therapy Xalkori. VENTANA ALK (D5F3) CDx Assay is intended for laboratory use in... […]
LEE011 (ribociclib, a selective cyclin dependent kinase inhibitor developed by Novartis, was granted Priority Review by FDA. FDA also accepted Novartis’s new Drug Application for filing as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with letrozole. The NDA is based on... […]
VENTANA PD-L1 assay received FDA approval as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer.
ALECENSARO (alectinib) received approval from Health Canada as a monotherapy for the treatment of patients with anaplastic lymphoma kinase-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. The drug is marketed under the name Alecensa in the US. The drug, which... […]
BRISTOL-MYERS SQUIBB was granted conditional approval by Health Canada for the treatment of previously untreated adults with unresectable or metastatic melanoma using Opdivo and Yervoy. The first-ever combination of two immuno-oncology agents has the potential to increase progression-free survival in certain patients. Health Canada also issued a Notice of Compliance with conditions for the OPDIVO... […]
