Cigna Corp. issued a positive coverage decision for VeriStrat serum proteomic testing developed by Biodesix Inc. Cigna published its position to extend coverage for the VeriStrat blood-based test, stating the test is “…medically necessary for an individual with advanced non-small cell lung cancer (NSCLC)…”
Amgen and Roche announced they will collaborate on a phase Ib study to evaluate the safety and efficacy of talimogene laherparepvec, Amgen's investigational oncolytic immunotherapy, in combination with Roche's investigational anti-PDL1 therapy, atezolizumab (also known as MPDL3280A), in patients with triple-negative breast cancer and colorectal cancer with liver metastases.
Advaxis Inc. submitted a Special Protocol Assessment request to the FDA to initiate detailed design discussions for a phase III clinical study of ADXS-HPV for the treatment of high-risk, locally advanced cervical cancer.
FDA approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to aid in the identification of patients for Pfizer's targeted therapy, Xalkori (crizotinib).
The European Commission has granted marketing authorization for Gardasil 9.
Lenvima (lenvatinib) launched in the U.K. as a treatment option for adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Janssen Research & Development initiated the rolling submission of its Biologic License Application for daratumumab to FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a PI and an IMiD.
Lenvima (lenvatinib) launched in the U.K. as a treatment option for adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
MD Anderson Cancer Center and Nektar Therapeutics announced a research collaboration that includes a phase I/II clinical study to evaluate NKTR-214, a CD122-biased cytokine designed to preferentially stimulate production of CD8-positive T cells.
FDA granted an orphan drug designation for APTO-253 for the treatment of acute myeloid leukemia.
