FDA has accepted a supplemental New Drug Application and granted priority review for Keytruda (pembrolizumab), an anti-PD-1 therapy.
Eli Lilly and Co. said FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
Yisheng Biopharma Co., Ltd., said the FDA has granted orphan drug designation for its lead immuno-oncology candidate, YS-ON-001, for pancreatic cancer.
The FDA has approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation.
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
FDA approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy. This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
Roche and Flatiron Health Inc. announced today that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing equity stake of 12.6%. The transaction is expected to close in the first half of 2018.
Bristol-Myers Squibb Co. and Nektar Therapeutics executed a global strategic development and commercialization collaboration for Nektar's lead immuno-oncology program, NKTR-214. Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with BMS's Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) in more than 20 indications across nine tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties.
The United Kingdom's National Institute for Health and Care Excellence has published a Final Appraisal Determination recommending FOTIVDA (tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma.
FDA approved abiraterone acetate (Zytiga) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). The drug is sponsored by Janssen Biotech Inc.
Foundation Medicine Inc. and the European Organisation for Research and Treatment of Cancer announced a collaboration in which Foundation Medicine's comprehensive genomic profiling tests will be used to inform patient eligibility for oncology clinical trials through the EORTC's Screening Patients for Efficient Clinical Trial Access program, which is a pan-European network built by the EORTC with key institutions collaborating to provide efficient access for patients to molecularly driven clinical trials.
