Memorial Sloan Kettering Cancer Center

Revumenib approved for R/R KMT2A-rearranged acute leukemia; datopotamab deruxtecan seeks accelerated approval for EGFR-mutated NSCLC; managing CML requires open communication; CLL patients progressing despite BTK inhibitors and venetoclax; quadruplet regimen shows improved response in transplant-eligible multiple myeloma.

The FDA granted accelerated approval to zanidatamab for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, based on a 52% overall response rate in the HERIZON-BTC-01 trial. Common adverse effects included diarrhea, infusion-related reaction, abdominal pain, and fatigue. The ongoing HERIZON-BTC-302 trial will confirm efficacy in the frontline setting.

FDA approved zolbetuximab-clzb (Vylov) plus chemotherapy for HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma, addressing unmet need in PD-L1–low/HER2-negative patients. Routine CLDN18.2 testing is crucial for targeted therapy in previously non-targetable populations.

SOPHiA GENETICS launched MSK-IMPACT powered with SOPHiA DDM at AMP Annual Meeting, offering high-accuracy, efficient comprehensive genomic profiling. This expands precision oncology access globally, enhancing somatic mutation detection and benefiting from SOPHiA GENETICS’ network. Sofiva Genomics in Taiwan is among the first adopters, highlighting the technology's impact on localized genomic testing and cancer research.

Nobel Laureate Dr. Harold Varmus spoke at HudsonAlpha Institute, discussing his career, discoveries of oncogenes, and principles for a life in science. He emphasized the societal benefits of science and the potential of combined therapies in cancer treatment.

Jazz Pharmaceuticals announced FDA accelerated approval of Ziihera (zanidatamab-hrii) for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Ziihera, a dual HER2-targeted bispecific antibody, demonstrated a 52% objective response rate and a median duration of response of 14.9 months. Continued approval may depend on results from the ongoing phase 3 HERIZON-BTC-302 trial. The approval addresses a significant unmet need for effective therapies in this patient population.

Ziihera, a dual HER2-targeted bispecific antibody, received accelerated FDA approval for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) with a 52% objective response rate and median duration of response of 14.9 months. Continued approval may depend on results from the ongoing Phase 3 HERIZON-BTC-302 trial.

Memorial Sloan Kettering Cancer Center publishes CT scan dataset of 32 lung cancer patients with annotated lesion contours for AI training.

FDA grants accelerated approval to zanidatamab for pretreated HER2-positive biliary tract cancer, with HER2 positivity defined as IHC score of 3+. HERIZON-BTC-01 trial showed 52% response rate, 14.9 months duration of response. Ongoing phase III trial HERIZON-BTC-302 to confirm benefit. Common AEs include diarrhea, infusion-related reactions, abdominal pain, and fatigue.

The FDA approved zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2+ biliary tract cancer, based on the phase 2b HERIZON-BTC-01 trial showing a 52% ORR and 14.9-month median DOR. This marks the first HER2-targeted treatment for this condition.