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.
FDA has approved the BRACAnalysis CDx test for use as a companion diagnostic to identify men with metastatic castration-resistant prostate cancer who are eligible for treatment with Lynparza (olaparib).
Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application to FDA, seeking approval for Xpovio (selinexor), its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with previously treated multiple myeloma.
