Courtney Flaherty

An NDA for lirafugratinib in pretreated, FGFR2-altered cholangiocarcinoma was accepted for FDA review and assigned a PDUFA date of September 27, 2026.

We recap the top regulatory decisions of March in GI malignancies.

The ETOP ADEPPT trial met its primary end point with a 31% 12-week ORR with adagrasib in patients at least 70 years old with an ECOG PS of 0 or 1.

R. Lor Randall, MD, FACS, highlights primary objectives of, and key takeaways from, the BOOM consensus meeting on PJI management in orthopedic oncology.

However, a trend towards OS benefit was observed when treatment with cabozantinib was deferred until after disease progression vs administered upfront.

Vincent Picozzi, MD, discusses the importance of the FDA approval of Optune Pax for TTField development in locally advanced pancreatic cancer.

Marwan G. Fakih, MD, discusses the implications of the FDA approval of retifanlimab plus chemotherapy for the evolving role of immunotherapy in SCAC.

Rachna T. Shroff, MD, MS, FASCO, discusses how this “sea change” has coincided with evolving considerations for frontline selection in pancreatic cancer.

Kanwal P.S. Raghav, MD, MBBS, discusses a phase 2 study evaluating the MET-directed ADC Temab-A vs SOC active surveillance in postadjuvant, ctDNA-positive CRC.

John L. Marshall, MD, and Christopher Lieu, MD, comment on the rising incidence of early-onset colorectal cancer (CRC) during CRC Awareness Month.

Shubham Pant, MD, MBBS, discusses the importance of early biomarker testing in mCRC to guide targeted therapy selection and ensure full clinical benefit.

The FDA has tentatively approved the abbreviated new drug application for the lutetium lu 177 dotatate radioequivalent PNT2003 in SSTR-positive GEP-NETs.

Deep and durable responses were maintained with cabozantinib plus nivolumab in long-term follow-up of the CheckMate 9ER trial.

February brought key GI cancer updates: FDA approvals in BRAF+ mCRC and pancreatic cancer, plus new fast track and orphan designations.

Adding cabazitaxel to ADT and radiotherapy did not improve PFS or MFS vs SOC after 7 years among patients with high-risk localized prostate cancer.

Richard D. Kim, MD, discusses how positive results from PODIUM-303 exemplify and support the shift towards chemoimmunotherapy regimens in frontline SCAC.

Encorafenib plus cetuximab and fluorouracil-based chemotherapy has received traditional FDA approval for BRAF V600E–mutant metastatic colorectal cancer.

R. Lor Randall, MD, FACS, discusses a report on factors predicting local recurrence in nonmetastatic Ewing sarcoma from the phase 3 AEWS1031 trial.

Deirdre J. Cohen, MD, MS, discusses key considerations when navigating first-line chemotherapy selection in metastatic pancreatic cancer.

Topline data from cohort 3 of BREAKWATER showed improvements in key secondary end points of PFS and OS in previously treated, BRAF V600E–mutant mCRC.

Benjamin A. Weinberg, MD, FACP, discusses the specific therapeutic goals and challenges of third-line metastatic colorectal cancer management.

The portable, noninvasive device has been approved for concomitant use with gemcitabine and nab-paclitaxel in locally advanced pancreatic cancer.

Manish A. Shah, MD, and Raji Shameem, MD, discuss potentially paradigm-shifting results from the HERIZON-GEA-01 study.

Philippos Costa, MD, and Hari Deshpande, MD, discuss chondrosarcoma staging, diagnosis, surgery, and future research avenues in this clinician-focused FAQ.

With an additional 16.1 months of follow-up, the dual HER2-targeted, chemotherapy-free regimen maintained efficacy and safety in HER2-positive mCRC.

Pelareorep has received FDA fast track designation in combination with SOC bevacizumab and FOLFIRI in the second line for KRAS-mutant MSS mCRC.

Ryan D. Chow, MD, PhD, Ronac Mamtani, MD, MSCE, and Ramy Sedhom, MD, spotlight a real-world analysis of upfront enfortumab vedotin dose reduction in bladder cancer.

An NDA for zanzalintinib plus atezolizumab in pretreated metastatic colorectal cancer is under review by the FDA.

Dana M. Chase, MD, Robert Neff, MD, and Maurie Markman, MD, comment on the current state of HPV vaccination and screening during cervical cancer awareness month.

An NDA for lirafugratinib in the second line for patients with FGFR2-altered cholangiocarcinoma has been submitted to the FDA.