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Oncology Newsfeed

  • FDA Approves Ramucirumab + Erlotinib for First-Line Treatment of Metastatic NSCLC

    On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.

    Read full FDA announcement.

    Posted 6/2/2020


  • FDA Approves Nivolumab+Ipilimumab Combo as 1st Line Treatment for Metastatic NSCLC

    On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol Myers Squibb Co.) plus ipilimumab (Yervoy, Bristol Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

    Read full FDA announcement.

    Posted May 27, 2020



  • FDA Approves Brigatinib for ALK-Positive Advanced NCSLC

    On May 22, 2020, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

    On the same day, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic for brigatinib.

    Read full FDA announcement.

    Posted 5/26/2020



  • FDA Approves Olaparib for HRR Gene-Mutated mCRPC

    On May 19, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.

    On the same day, the FDA also approved FoundationOne CDx (Foundation Medicine, Inc.) for selection of patients with mCRPC carrying HRR gene alterations and BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) for selection of patients with mCRPC carrying germline BRCA1/2 alterations as companion diagnostic devices for treatment with olaparib.  

    Read full FDA announcement.

    Posted 5/20/2020



  • FDA Approves Atezolizumab for 1st-Line Treatment in Some Advanced NSCLC

    On May 18, 2020, the U.S. Food and Drug Administration approved atezolizumab (Tecentriq®) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations.

    On the same day, the FDA also approved the VENTANA PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with atezolizumab.

    Read the full FDA announcement. 

    Posted 5/19/2020



  • FDA Approves Ripretinib for Previously Treated Advanced GIST

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

    Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with GIST who were previously treated with imatinib, sunitinib, and regorafenib. 

    Read the full FDA announcement. 

    Posted 5/15/2020



  • FDA Approves Rucaparib for Pretreated BRCA-Mutated mCRPC

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

    Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial in 115 patients with BRCA-mutated (germline and/or somatic) mCRPC who had been treated with androgen receptor-directed therapy and taxane-based chemotherapy.

    Read full FDA announcement.

    Posted 5/15/2020


  • FDA Approves Nivolumab + Ipilimumab Combination for Metastatic NSCLC

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) 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 (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

    The FDA also approved the PD-L1 IHC 28-8 pharmDx (Agilent Technologies, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with nivolumab plus ipilimumab.

    Read full FDA announcement. 

    Posted 5/15/2020


  • FDA Grants Accelerated Approval to Pomalidomide for Karposi Sarcoma

    On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy (HAART) and Kaposi sarcoma in adult patients who are HIV-negative.

    This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Read the FDA announcement.

    Posted 5/15/2020


  • FDA Approves Olaparib + Bevacizumab as Maintenance Treatment for Advanced Ovarian Cancer

    On May 8, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic test.

    Read FDA announcement.

    Read the corporate press release. 

    Posted 5/11/2020