FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
FDA allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome and myeloproliferative neoplasms.
Novartis said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative locally advanced or metastatic breast cancer as initial endocrine-based therapy.
Novartis said the European Commission approved expanding the use of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive.
FDA unveiled a plan to eliminate the agency's existing orphan designation request backlog and ensure response to new requests for designation with deadlines.
FDA granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.
FDA granted regular approvals to dabrafenib and trametinib (Tafinlar and Mekinist) administered in combination for patients with metastatic non-small cell lung cancer with BRAF V600E mutation as detected by an FDA-approved test.
FDA granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer.
FDA rejected Pfizer's Biologics License Application for its proposed epoetin alfa biosimilar to Amgen's Epogen, citing significant violations of good manufacturing practice regulations for finished pharmaceuticals at the company's drug manufacturing facility, Hospira Inc., in McPherson, KS.