Chris Ryan

Geneoscopy has submitted a premarket approval application to the FDA for a noninvasive, stool-based, at-home screening test to detect colorectal cancer and advanced adenomas in average-risk individuals.

The FDA has granted a priority review to the supplemental new drug application (sNDA) to avapritinib for the treatment of adult patients with indolent systemic mastocytosis.

First-line treatment with the combination of liposomal irinotecan plus 5-fluorouracil, leucovorin, and oxaliplatin produced a clinically meaningful and statistically significant improvement in overall survival and progression-free survival vs nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma, according to results from the phase 3 NAPOLI 3 trial.

The FDA has granted a fast track designation to EVX-01 in combination with pembrolizumab for the treatment of patients with metastatic melanoma.

The FDA has granted accelerated approval to tucatinib in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed after treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

The Medicines and Healthcare Products Regulatory Agency has approved zanubrutinib in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia and the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20–based therapy.

Adjuvant treatment with the combination of atezolizumab and bevacizumab demonstrated a statistically significant improvement in recurrence-free survival compared with active surveillance in patients with early-stage hepatocellular carcinoma at high risk of disease recurrence.

Perioperative treatment with the combination of toripalimab plus platinum-containing doublet chemotherapy, followed by toripalimab monotherapy as consolidation therapy after surgery, significantly extended event-free survival compared with chemotherapy plus placebo in patients with operable NSCLC.

The PIM1 kinase inhibitor TP-3654 was well tolerated and showcased preliminary signs of activity, including spleen volume reduction, symptom improvement, and broad cytokine reduction, in patients with myelofibrosis who were previously treated with or were ineligible for a JAK inhibitor.

Moxetumomab pasudotox-tdfk will be permanently discontinued in the United States market for the treatment of relapsed/refractory hairy cell leukemia.

The combination of BXCL701 and pembrolizumab produced encouraging responses in patients with small cell neuroendocrine carcinoma metastatic castration-resistant prostate cancer, according to topline data from a phase 2 trial.

The FDA has granted a fast track designation to best-in-class threonine tyrosine kinase inhibitor CFI-402257 for the treatment of adult patients with estrogen receptor (ER)–positive/HER2-negative advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy.

Geneoscopy’s at-home, stool-based diagnostic screening test to detect colorectal cancer and advanced adenomas in average-risk individuals displayed high sensitivity and specificity, meeting the primary objectives of the phase 3 CRC-PREVENT trial.

The Center for Drug Evaluation of China's National Medical Products Administration has granted a breakthrough therapy designation to IBI351 for the treatment of patients with advanced non–small cell lung cancer harboring a KRAS G12C mutation who have received at least 1 prior line of systemic therapy.

Tovorafenib monotherapy generated responses in patients with recurrent or progressive pediatric low-grade glioma.

The addition of abequolixron to docetaxel generated responses in patients with relapsed/refractory non–small cell lung cancer or small cell lung cancer.

The FDA has accepted a biologics license application for glofitamab for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

Adding the CDK4/6 inhibitor trilaciclib to platinum-based chemotherapy and avelumab maintenance produced an overall response rate comparable to chemotherapy and maintenance avelumab alone in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Tumor treating fields plus standard-of-care therapies led to a statistically significant and clinically meaningful improvement in overall survival vs SOC alone in patients with stage IV NSCLC who progressed while on or after platinum chemotherapy, meeting the primary end point of the LUNAR trial.

The FDA has granted breakthrough device designation for the TriNetra™-Glio blood test to help in the diagnosis of brain tumors.

The FDA has not sent an action letter regarding the biologics license application for toripalimab in combination with chemotherapy as treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.

A teenage injury cost him a career among the stars, so John F. DiPersio, MD, PhD, became a star hematologist/oncologist instead.

Japan’s Ministry of Health, Labor and Welfare has approved axicabtagene ciloleucel for the initial treatment of patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma.

The combination of domvanalimab plus zimberelimab with or without etrumadenant generated an improvement in overall response rate and progression-free survival compared with zimberelimab alone in patients with PD-L1–high metastatic non–small cell lung cancer, according to findings from the phase 2 ARC-7 trial.

The FDA has granted a breakthrough therapy designation to adagrasib plus cetuximab in patients with KRAS G12C–mutated, advanced colorectal cancer whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.

The European Commission has approved the combination of olaparib plus abiraterone acetate and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

The FDA has approved an additional indication for pemetrexed by injection, an alternative to standard pemetrexed, in combination with pembrolizumab and platinum-based chemotherapy for the initial treatment of patients with metastatic, nonsquamous non–small cell lung cancer without EGFR or ALK genomic tumor aberrations.

Zanidatamab monotherapy produced responses in previously treated patients with HER2-amplified and -expressing biliary tract cancers.

A biologics license application (BLA) has been submitted to the FDA for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma, according to an announcement from Janssen.

The combination of vusolimogene oderparepvec and nivolumab generated promising responses in patients with cutaneous melanoma who failed previous anti–PD-1 therapy, according to initial data from the phase 2 IGNYTE trial.