Illumina is working on a series of oncology partnerships that aim to expand the reach of its comprehensive genomic profiling family of products, TruSight Oncology.
FDA has approved Tagrisso (osimertinib) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Iclusig receives FDA sNDA approval for adult patients with resistant or intolerant chronic-phase CML
FDA has approved the supplemental New Drug Application for Iclusig (ponatinib) for adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.
FDA has approved Xpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
FDA has approved the first oral gonadotropin-releasing hormone receptor antagonist, Orgovyx (relugolix) for adult patients with advanced prostate cancer.
FDA has approved Margenza (margetuximab-cmkb) in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
FDA has granted Fast Track designation to CPI-613 (devimistat) for the treatment of acute myeloid leukemia.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, Merck's anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
Bayer and Veracyte have entered a collaboration to advance the Precision Oncology Patient Identification Program in thyroid cancer.
Servier has entered into an agreement for the acquisition of Agios Pharmaceuticals' oncology business including its commercial, clinical and research-stage oncology portfolio for up to $2 billion, including an upfront payment of $1.8 Billion and a potential $200 million in regulatory milestone, plus royalties.
