Garth W. Strohbehn

Jan 30, 2024 | nature.com | Garth W. Strohbehn

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. The activity of sotorasib in patients with KRASG12C-mutated non-small-cell lung cancer (NSCLC) has been demonstrated, which led to Accelerated Approval by the FDA in May 2021 (ref. 1).

Jan 5, 2024 | nature.com | Garth W. Strohbehn

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.

Nov 16, 2023 | jamanetwork.com | Bishal Gyawali |Garth W. Strohbehn

Immunotherapy in Prepatients—Preventing or Promoting a Malignant Transformation? Nivolumab for Patients With High-Risk Oral Leukoplakia Glenn J. Hanna, MD; Alessandro Villa, DDS, PhD; Shuvro P. Nandi, PhD; Ruichao Shi; Anne ONeill; Mofei Liu; Charles T. Quinn; Nathaniel S. Treister, DMD; Herve Y. Sroussi, DMD, PhD; Piamkamon Vacharotayangul, DDS, PhD; Laura A. Goguen, MD; Donald J. Annino Jr, MD, DMD; Eleni M. Rettig, MD; Vickie Y. Jo, MD; Kristine S.