The National Comprehensive Cancer Network Oncology Research Program announces plans to develop a program to scientifically evaluate and facilitate clinical trials on the efficacy of trifluridine and tipiracil chemotherapy.
FDA has approved BRACAnalysis CDx to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer's PARP inhibitor, Talzenna (talazoparib).
FDA announced the availability of the draft guidance titled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biologic Products for Treatment.”
Some European countries take more than twice as long as others to reach health technology assessment decisions to reimburse new cancer drugs following their approval by the European Medicines Agency.
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.
