
Precision Medicine in Oncology®
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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.

FDA Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma
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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.

In this seventh episode of OncChats: Examining the Promise of Multicancer Early Detection Tests, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Niloy Jewel J. Samadder, MD, discuss the data that are still needed to inform optimal utilization of multicancer early detection tests and their potential cost effectiveness.

The FDA has approved the LeukoStrat CDx FLT3 Mutation Assay for use as a companion diagnostic to select patients with FLT3-ITD–positive acute myeloid leukemia who may be eligible to receive treatment with quizartinib (Vanflyta).1

Melissa L. Johnson, MD, discusses the development of the seizure-related homolog protein 6–targeting antibody-drug conjugate ABBV-011 and outcomes with this agent in patients with small cell lung cancer.

Adnan F. Danish, MD, discusses the use of SCINTIX radiation technology in metastatic bone and lung tumors.

In this sixth episode of OncChats: Examining the Promise of Multicancer Early Detection Tests, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Niloy Jewel J. Samadder, MD, discuss important takeaways from the ECLIPSE study (NCT04136002), which evaluated a cell-free DNA blood-based test for colorectal cancer in an average-risk population.

Adnan F. Danish, MD, discusses unmet needs in the treatment of patients with lung and bone cancers, and how unmet needs within this patient population are being addressed with the utilization of SCINTIX radiation technology.

Adnan F. Danish, MD, discusses the use of novel radiotherapy approaches in cancer care.

Adnan F. Danish, MD, discusses current unmet needs in the treatment of patients with stage IV lung and bone cancers, the benefits SCINTIX technology can provide for these patients, and how John Theurer Cancer Center plans to use this technology to improve patient outcomes and support further radiation therapy research.

In this fifth episode of OncChats: Examining the Promise of Multicancer Early Detection Tests, Toufic A. Kachaamy, MD, Madappa Kundranda, MD, PhD, and Niloy Jewel J. Samadder, MD, walk through the key lessons learned from the prospective, multicenter PATHINDER study (NCT04241796), which evaluated a multicancer early detection test developed by GRAIL.

The FDA has granted a fast track designation to paxalisib in combination with radiation therapy for the treatment of patients with solid tumor brain metastases harboring PI3K pathway mutations.

Ixabepilone produced clinical benefit in patients with metastatic breast cancer selected for treatment with the DRP®-IXEMPRA® companion diagnostic candidate.

























































