Noted This Week

May 15–21

It was another busy week for the FDA, which approved a spate of oncology agents for new indications:

  • the PD-1 inhibitor nivolumab (Opdivo; Bristol-Myers Squibb) plus the CTLA4 inhibitor ipilimumab (Yervoy; Bristol-Myers Squibb) as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) who express PD-L1 and who don’t have EGFR or ALK alterations. The approval was based on a subgroup analysis of the phase III CheckMate-227 trial, in which patients treated with the combination had a median overall survival (OS) of 17.1 months, compared with 14.9 months in patients who received chemotherapy. The agency also approved the PD-L1 IHC 28-8 pharmDx (Agilent Technologies) as a companion diagnostic.
  • the PD-L1 inhibitor atezolizumab (Tecentriq; Genentech) as a first-line therapy for patients with metastatic NSCLC who have high PD-L1 expression and who don’t have EGFR or ALK alterations. The approval was based on the IMpower110 trial, in which patients treated with the agent had a median OS of 20.2 months, compared with 13.1 months in patients who received chemotherapy. The agency also approved the Ventana PD-L1 Assay (Ventana Medical Systems) as a companion diagnostic.
  • the PARP inhibitor rucaparib (Rubraca; Clovis Oncology) for patients with BRCA-mutant metastatic castration-resistant prostate cancer who have already received androgen receptor–directed therapy and a taxane-based chemotherapy. The approval was based on the phase II TRITON2 trial, in which patients had an objective response rate of 44%. The agency also approved the BRACAnalysis CDx (Myriad Genetics) as a companion diagnostic.
  • the PARP inhibitor olaparib (Lynparza; AstraZeneca) for patients with metastatic castration-resistant prostate cancer who have homologous recombination repair gene alterations. The approval was based on the phase III PROfound trial, in which patients treated with the agent had a median radiologic progression-free survival (PFS) of 7.4 months and a median OS of 19.1 months, compared with 3.6 months and 14.7 months in patients who received standard enzalutamide or abiraterone acetate. The FDA also approved FoundationOne CDx (Foundation Medicine) as a companion diagnostic.
  • the KIT and PDGFRα inhibitor ripretinib (Qinlock; Deciphera Pharmaceuticals) for patients with advanced gastrointestinal tumors who have received at least three kinase inhibitors, including imatinib (Gleevec; Novartis). The approval was based on the phase III INVICTUS trial, in which patients treated with the drug had a median PFS of 6.3 months and a median OS of 15.1 months, compared with 1 month and 6.6 months in patients who received a placebo.
  • the antiangiogenic agent pomalidomide (Pomalyst; Celgene) for patients with AIDS-related Kaposi sarcoma whose disease does not respond to highly active antiretroviral therapy, or patients with Kaposi sarcoma who are HIV-negative. The approval was based on the phase I/II 12-C-0047 trial, in which patients had an overall response rate of 71% and a median duration of response of 21.1 months.

Preliminary findings suggest that the Bruton tyrosine kinase inhibitor ibrutinib (Imbruvica; Janssen) may alleviate respiratory symptoms in patients with COVID-19 infections. Five patients taking a standard dose of ibrutinib for Waldenström macroglobulinemia who developed COVID-19 experienced no shortness of breath and did not require hospitalization; a sixth patient on a lower dose of ibrutinib was placed on a ventilator, but rapidly improved when the dose was increased. A clinical trial is testing ibrutinib in patients with moderate to severe COVID-19.

The Cancer Prevention Research Institute of Texas in Austin awarded $56 million in grants to researchers at institutions in Texas, including The University of Texas MD Anderson Cancer Center in Houston and The University of Texas Southwestern Medical Center in Dallas. Grantees will use the money for research in areas such as positron emission tomography radiochemistry, oncogene addiction, and novel targeted agents.


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