GI CANCERS

Excitement surrounds systemic therapies for hepatocellular carcinoma, with 1 new drug recently approved, 2 agents pending FDA decisions, and later-stage clinical trials for multiple therapies on the horizon.

Today, ABP-215, a biosimilar for bevacizumab developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.

The decision deadline on a biologics license application (BLA) for MYL-1401O, a trastuzumab (Herceptin) biosimilar co-developed by Mylan and Biocon, has been extended by 3 months, the FDA has announced. Under the new timeframe, a final decision is expected on or before December 3, 2017.

Mark S. Talamonti, MD, clinical professor, NorthShore University HealthSystem, discusses the learning curve for minimally invasive surgery in gastrointestinal cancers.

Antonia R. Sepulveda, MD, PhD, discusses&nbsp;the importance and utility of genetic testing in GI cancers, as well as noteworthy developments in microsatellite instability, <em>BRAF</em>, and <em>KRAS </em>testing in colorectal cancer.

Manuel Hidalgo, MD, shares his insight on the growth of genetic testing in CRC.<br /> &nbsp;

Manish A. Shah, MD,&nbsp;director of gastrointestinal oncology, Weill Cornell Medicine and New York-Presbyterian Hospital, discusses the decreasing incidence of colon cancer diagnosis in those over the age of 50.

In patients with heavily-pretreated microsatellite stable metastatic colorectal cancer (mCRC), treatment with CEA-TCB, an investigational CEA/CD3 bispecific antibody, showed a favorable safety profile and promising efficacy, with enhanced efficacy when combined with the PD-L1 inhibitor atezolizumab.

Dominik P. Modest, MD, discusses a retrospective, central evaluation of the FIRE-3 study to determine surgical treatment options, which explored the number of patients with metastatic colorectal cancer who had resectable disease during systemic first-line therapy.&nbsp;

Nivolumab (Opdivo) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Diane M. Simeone, MD, is stepping up to lead the new Pancreatic Cancer Center at NYU Langone. She has been a member of NYU Langone since March 2017, and will continue in her role as associate director of translational research at the Perlmutter Cancer Center.

Recurrent Metastatic Gastrointestinal Stromal Tumor

Lutathera (lutetium [¹⁷⁷Lu] oxodotreotide) has been recommended for approval by the European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with unresectable or metastatic, progressive, well-differentiated (grade 1 and grade 2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Tanios Bekaii-Saab, MD, discusses the&nbsp;the promise of napabucasin in pancreatic cancer.

In a 17-0 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee&nbsp;unanimously recommended the approval of ABP-215, a biosimilar for bevacizumab.

Weijing Sun, MD, has been appointed the new Sprint Foundation Professor of Medical Oncology and the director of the Division of Medical Oncology at The University of Kansas School of Medicine and The University of Kansas Cancer Center.

David J. Pinato, MD, PhD, NIHR Academic Clinical Lecturer in Medical Oncology, resident, Royal Brompton Hospital and Imperial College London, discusses an analysis of intra-tumor heterogeneity in the regulation of immune-tolerogenic pathways in primary and metastatic hepatocellular carcinoma (HCC).&nbsp;

Ann-Lii Cheng, MD, discusses a phase III trial of lenvatinib vs sorafenib in the first-line treatment of patients with unresectable hepatocellular carcinoma.

Luis A. Diaz Jr, MD, head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, discusses the recent FDA approval of pembrolizumab (Keytruda) for microsatellite instability-high (MSI-H) colorectal cancer and other tumor types.