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Early Cytogenetic or Molecular Landmark Response to Ponatinib Predicts Outcomes in CP-CML
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In this second episode of OncChats: Leveraging Endoscopic Ultrasound in Pancreatic Cancer, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Tamas A. Gonda, MD, discuss the techniques used such as endoscopic ultrasound–guided biopsies to collect adequate tissue to perform genomic analyses in pancreatic cancer, and the likelihood for finding actionable mutations in this population.

Treatment with the KRAS G12C inhibitor divarasib (formerly GDC-6036) led to durable responses with a tolerable safety profile in patients with a variety of solid tumors harboring a KRAS G12C mutation.

Sanjay Goel, MD, MS, discusses the safety profile of the TKI tinengotinib as a monotherapy and in combination with chemotherapy in patients with solid tumors.

Corey J. Langer, MD, outlines the prevalence of BRAF mutations in NSCLC and looked ahead to where the development pipeline of agents for the treatment of patients with BRAF-mutated NSCLC is headed.

Sanjay Goel, MD, MS, discusses the mechanism of action of tinengotinib and the efficacy of this agent in patients with cholangiocarcinoma.

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.

Savolitinib Wins Breakthrough Therapy Designation in China for Gastric Cancer With MET Amplification
The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.

A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.

In this first episode of OncChats: Leveraging Endoscopic Ultrasound in Pancreatic Cancer, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Tamas A. Gonda, MD, discuss how endoscopic ultrasound has changed the diagnosis of pancreatic cancer and how it may also be utilized to guide personalized treatment in nonmetastatic adenocarcinomas.

The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.

Treatment with erdafitinib resulted in clinical benefit for patients with advanced solid tumors harboring susceptible FGFR alterations who had exhausted all other treatment options, meeting the primary end point of overall response rate of the phase 2 RAGNAR trial.

Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.

Selpercatinib demonstrated a statistically significant improvement in progression-free survival vs physician’s choice of cabozantinib or vandetanib in patients with advanced or metastatic RET-mutant medullary thyroid cancer, meeting the primary end point of the phase 3 LIBRETTO-531 trial.

Praful K. Ravi, MB, BChir, MRCP, discusses the use of prostate-specific membrane antigen-targeted therapies in metastatic castration-resistant prostate cancer, highlighting the use of the targeted radioligand lutetium Lu 177 vipivotide tetraxetan.

Zeynep Eroglu, MD, explains the rationale for adding navitoclax to dabrafenib plus trametinib in the treatment of patients with BRAF V600–mutant metastatic melanoma, highlights the methodologies and results of the CTEP-P9466 trial, and describes the implications of this research for this patient population.

The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.

The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

The first patients have been dosed in the phase 2 portion of a phase 1/2 trial evaluating BDC-1001 monotherapy in patients with HER2-positive colorectal cancer, endometrial cancer, and gastroesophageal cancer.

China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.

Adnan F. Danish, MD, discusses the potential for SCINTIX radiation technology to open new treatment opportunities for patients with cancer, including those with lung and bone cancers, whose disease has metastasized to more than 5 sites.

The FDA has approved the therascreen PDGFRA RGQ PCR kit for use as a companion diagnostic, co-developed by Qiagen and Blueprint Medicines, to assist in the identification of patients with gastrointestinal stromal tumors who may be candidates to receive avapritinib.

Adnan F. Danish, MD, discusses the methodologies behind the use of SCINTIX radiation technology in metastatic bone and lung tumors, detailing how this technology differs from computed tomography or magnetic resonance imaging scans prior to treatment.

Emerging strategies leveraging biomarker data for the treatment of patients with early-stage and metastatic colorectal cancer have made precision medicine a top-of-mind topic for gastrointestinal oncologists.

Lyudmila A. Bazhenova, MD, discusses potential combination strategies with KRAS G12C inhibitors in advanced non–small cell lung cancer.

Hatim Husain, MD, discusses developments in ALK-positive non–small cell lung cancer.











































