AbbVie said FDA has accepted its supplemental New Drug Application for Priority Review for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The Parker Institute for Cancer Immunotherapy and Xyphos Biosciences announced a collaboration to create universal CAR-T therapies to treat multiple cancer types using the company's “convertibleCAR” platform.
PanTher Therapeutics announced an agreement with MD Anderson Cancer Center and the appointment of a new senior clinical advisor. The collaboration will support preclinical testing of PanTher's lead product for pancreatic cancer, PTM-101, and is intended to demonstrate readiness for future human clinical trials.
The FDA Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody biosimilar to Rituxan (rituximab) for the treatment of adult patients in three proposed indications.
Myriad Genetics Inc. and Pfizer Inc. announced a commercialization plan under an existing companion diagnostic agreement, in which Myriad is pursuing FDA approval for its BRACAnalysis CDx to be used as a companion diagnostic with Pfizer's investigational PARP inhibitor, talazoparib.
Foundation Medicine Inc. said that FoundationOne Liquid, a liquid biopsy test for solid tumors, is commercially available in the U.S.
Celyad announced an exclusive agreement with Horizon Discovery Group plc, for the use of its shRNA technology to generate Celyad's second non-gene- edited allogeneic platform.
A UPMC-developed test for diagnosis of thyroid nodules, ThyroSeq Genomic Classifier, has been approved for coverage by its Medicare Administrative Contractor, Novitas Solutions. This decision paves the way for the test to be accessible to more than 50 million Medicare patients nationwide.
FDA has published a draft guidance titled “Master Protocols--Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics.”
FDA has approved the supplemental New Drug Application to expand the prescribing information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma.