Gastrointestinal Cancer | Specialty

FDA Approves Pembrolizumab for HER2+ Gastric Cancer

May 5th 2021

The FDA has approved pembrolizumab for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.

FDA Grants Priority Review to Ivosidenib in IDH1-Mutant Cholangiocarcinoma

May 5th 2021

The FDA has granted a priority review to the supplemental new drug application for ivosidenib tablets as a treatment option for patients with previously treated, IDH1-mutant cholangiocarcinoma.

Rolling Submission Completed for Surufatinib in Advanced Neuroendocrine Tumors

May 3rd 2021

The rolling submission of a new drug application to the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors has been completed.

Dr. Jones on Future Research Efforts in Pancreatic Cancer

May 3rd 2021

Amy Jones, MD, discusses future research efforts in pancreatic cancer.

Trastuzumab Deruxtecan Under Investigation in HER2+ CRC in DESTINY-CRC02 Trial

May 3rd 2021

The first patient has received treatment with fam-trastuzumab deruxtecan-nxki in the phase 2 DESTINY-CRC02 trial, which is exploring the safety and efficacy of the antibody-drug conjugate in patients with HER2-overexpressing, BRAF wild-type, RAS-mutant or wild-type or mutant locally advanced, unresectable or metastatic colorectal cancer who have progressed following treatment with standard chemotherapy.

Dr. Kim on the FDA Approval of TheraSphere Y-90 Glass Microspheres in HCC

April 30th 2021

Edward Kim, MD, discusses the FDA approval of TheraSphere™ Yttrium-90 Glass Microspheres in hepatocellular carcinoma.

FDA Panel Opposes Nivolumab for Second-line Advanced HCC

April 29th 2021

In a 5 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee voted to oppose maintaining the accelerated approval of nivolumab monotherapy for patients with advanced hepatocellular carcinoma who received prior treatment with sorafenib.

Riedel and Van Tine Spotlight Sarcoma Advances and Preview Ongoing Studies

April 29th 2021

Dr. Riedel and Dr. Van Tine discuss the multidisciplinary management of patients with sarcoma, the clinical impact of the FDA approval of ripretinib in the gastrointestinal stromal tumor paradigm, and other exciting advances in sarcoma.

ODAC Unanimously Backs Pembrolizumab for Second-line Advanced HCC

April 29th 2021

In an 8 to 0 vote, the FDA’s Oncologic Drugs Advisory Committee voted to support the accelerated approval of pembrolizumab monotherapy for patients with advanced hepatocellular carcinoma who received prior treatment with sorafenib.

ODAC Votes Against Pembrolizumab for PD-L1+ Gastric/GEJ Cancer

April 29th 2021

In a 6 to 2 vote, the FDA’s Oncologic Drugs Advisory Committee voted against maintaining the accelerated approval of pembrolizumab for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more lines of therapy.

Atezolizumab/Bevacizumab Combo Sets the Standard for New Doublets in Advanced HCC

April 29th 2021

The combination of atezolizumab and bevacizumab has become the frontline standard of care for most patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Amgen Acquires Five Prime for its Oncology Pipeline

April 28th 2021

Amgen has completed its planned acquisition of Five Prime Therapeutics for $38.00 per share in cash, or approximately $1.9 billion.

Landscape for Unresectable HCC Comes Into Sharper Focus

April 27th 2021

After years of stagnation, the paradigm for treating patients with unresectable intermediate-stage or advanced hepatocellular carcinoma is starting to change as a result of novel strategies and evolving views of appropriate patient populations for systemic therapies.

FDA Approval Insights: TheraSphere Y-90 Glass Microspheres in HCC

April 26th 2021

Riad Salem, MD, discusses the unique elements of the TheraSphere, the data that supported the regulatory approval, and the anticipated future for the radioembolization technology in hepatocellular carcinoma.

UCSD Experts Tackle Reversing Cancer's Gluttony

April 26th 2021

ODAC Hearings on 6 Immunotherapy Indications Set to Begin

April 26th 2021

The FDA’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.

PD-1 Regimens Lead Charge Against Gastrointestinal Cancers

April 25th 2021

With immunotherapy options expanding for patients with a range of gastrointestinal cancers to include combination strategies with chemotherapy, their use in the treatment course should come sooner rather than later for those with high PD-L1 expression.

Toripalimab/Chemo Combo Improves Survival in Frontline Esophageal Squamous Cell Carcinoma

April 22nd 2021

The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.

Partner Perspectives: Moving Cholangiocarcinoma Into the Age of Targeted Therapy

April 22nd 2021

The plethora of actionable targets in intrahepatic cholangiocarcinoma has created opportunities for these patients to be treated with targeted therapy.

Dr. Lavery on Achieving Safe Care for Esophagogastric Cancer During COVID-19

April 22nd 2021

Anita Lavery, MD, MRCP, discusses achieving safe care for patients with esophagogastric cancer during the COVID-19 pandemic.