FDA has accepted the supplemental Biologics License Application for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma.
FDA has made labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate (for) injection, and vinorelbine tartrate injection.
FDA has approved Xalkori (crizotinib) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is ALK-positive.
FDA has granted orphan drug designation to Pvsripo for the treatment of advanced melanoma (stage IIB-IV).
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.
