Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim), received FDA approval.
Berubicin was granted Orphan Drug Designation by FDA for the treatment of malignant gliomas.
Atezolizumab in combination with bevacizumab was approved by FDA for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
Cyramza (Ramucirumab) was approved by FDA in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) mutations.
Piqray received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Sarclisa (isatuximab) was approved by the European Commission in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
The subcutaneous formulation of Darzalex (daratumumab) was granted marketing approval by the European Commission for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous formulation indications in frontline and relapsed / refractory settings.
FDA has approved Opdivo and Yervoy (nivolumab + ipilimumab) in combination with two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
Brigatinib (Alunbrig) has received FDA approval for adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
CLR 131 was granted FDA Fast Track Designation in lymphoplasmacytic lymphoma (LPL)/Waldenstrom's macroglobulinemia in patients having received two prior treatment regimens or more.
