Chris Ryan joined OncLive in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com
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.
The development of zandelisib for the treatment of B-cell malignancies has been discontinued outside of Japan.
The FDA has granted a breakthrough therapy designation to revumenib for the treatment of adult and pediatric patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement.
Enrollment has been paused for a phase 1 trial investigating the peptide-drug conjugate TH1902 for the treatment of patients with sortilin-expressing cancers.
The combination of sintilimab and anlotinib elicited improved responses and progression-free survival compared with chemotherapy in previously untreated patients with metastatic non–small cell lung cancer.
The FDA has issued a complete response letter to the biologics license application seeking the approval of 131I-omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.
Dostarlimab plus standard-of-care chemotherapy, followed by dostarlimab alone, produced a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with primary advanced or recurrent endometrial cancer.
The FDA has granted an orphan drug designation to AUM302 for the treatment of patients with neuroblastoma.
The FDA has approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.
The European marketing authorization application of infigratinib for the treatment of advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements has been withdrawn by Helsinn Birex Pharmaceuticals.
The FDA has accepted a biologics license application seeking the approval of a reformulation of denileukin diftitox for use as a potential therapeutic option in patients with persistent or recurrent cutaneous T-cell lymphoma.
The FDA has granted a fast track designation to batiraxcept for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology–based and VEGF TKI–based therapies, either in combination or sequentially.
