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Showing 1–5 of 5 results
Advanced filters: Author: Garth W. Strohbehn Clear advanced filters

  • The US FDA Accelerated Approval of sotorasib required the sponsor to conduct a randomized trial that compared the safety and efficacy of the approved dose with a lower dose. These results, recently disclosed, have important implications for patients, payers, oncologists and the pharmaceutical industry.

    • Garth W. Strohbehn
    • Mark J. Ratain
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 21, P: 331-332

  • The FDA approval of perioperative pembrolizumab, an approach that combines neoadjuvant and adjuvant therapy with this agent, for patients with early stage non-small-cell lung cancer (NSCLC) contradicts its own stated standard for combination therapies. Given the large population of patients with early stage NSCLC and the high costs of pembrolizumab, whether the adjuvant component provides incremental benefit is an important question.

    • Garth W. Strohbehn
    • Bishal Gyawali
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 21, P: 249-250

  • Data from several trials support the efficacy of first-line tyrosine-kinase inhibitors combined with immune-checkpoint inhibitors (ICIs) in metastatic renal cell carcinoma. However, whether combining these drugs is preferable to using them sequentially remains unclear. Here, we assess the implications for patients and payers of limited access to second-line ICIs in the control arms of trials.

    • Garth W. Strohbehn
    • Daniel A. Goldstein
    Comments & Opinion
    Nature Reviews Clinical Oncology
    Volume: 18, P: 395-396

  • As pharmaceutical companies seek patent protection for combinations of cancer therapeutics, it is worthwhile to assess what constitutes an ‘unexpected result’ for the purpose of an appropriate patent and whether randomized, controlled trials of drug combinations have the ability to generate them.

    • Garth W. Strohbehn
    • Alec J. Kacew
    • Mark J. Ratain
    Comments & Opinion
    Nature Biotechnology
    Volume: 39, P: 1504-1510