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.
Opdivo + Yervoy combination receives FDA approval for first-line mNSCLC (PD-L1 tumor expression ≥1%)
FDA has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
FDA has expanded the indication of pomalidomide (Pomalyst) to include adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, and Kaposi sarcoma in adult patients who are HIV-negative.
FDA has granted an accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
FDA has approved ripretinib (Qinlock) Deciphera Pharmaceuticals LLC for adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib.
FDA has approved Tecentriq (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
FDA has approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, who have progressed following prior treatment with enzalutamide or abiraterone.
