FDA has published a guidance for industry on an optional streamlined submission process for determining whether investigational in vitro diagnostic in clinical trials for an oncology therapeutic is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.
The National Medical Products Administration in China approved Merck's Keytruda as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors express PD-L1, with no EGFR or ALK genomic tumor aberrations.
FDA approved Darzalex (daratumumab) Sept. 26 in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplant.
FDA has approved the Exact Sciences Corp. noninvasive colorectal cancer screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication for ages 50 and older.
The European Medicines Agency recommended approval for the oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia with a FLT3 mutation (FLT3mut+).
The European Medicines Agency Sept. 20 recommended approval of Bavencio (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma.
Celsius Therapeutics will apply its proprietary single-cell genomics platform to tissue samples from patients receiving immune checkpoint inhibitor therapies for triple-negative breast cancer, bladder cancer and kidney cancer, at cancer care providers in three countries.
Evotec SE and Takeda Pharmaceutical Co. Ltd. established at least five joint drug discovery programs.
Foundation Medicine Inc. and Natera Inc. will collaborate to develop and commercialize personalized circulating tumor DNA monitoring assays, which biopharmaceutical and clinical customers who order FoundationOne CDx would be able to access.
Adaptive Biotechnologies Corp. entered into a global agreement with Amgen to use Adaptive's next-generation sequencing-based clonoSEQ Assay to assess minimal residual disease across multiple drug development programs within the Amgen hematology portfolio.
