Chris Ryan

Articles

FDA Grants Priority Review to Revumenib for R/R KMT2A+ AML/ALL

March 26th 2024

The FDA granted priority review to the NDA seeking the approval of revumenib for the treatment of relapsed/refractory, KMT2A-rearranged acute leukemia.

Liposomal Annamycin Plus Cytarabine Generates Responses in AML

March 25th 2024

Liposomal annamycin plus cytarabine elicited responses in patients with acute myeloid leukemia, according to interim data from the phase 1b/2 MB-106 trial.

FDA Issues CRLs for Odronextamab in R/R Follicular Lymphoma and R/R DLBCL

March 25th 2024

The FDA issued complete response letters to the BLA for odronextamab in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.

Phase 2 IMscin002 Study Shows Patients With NSCLC Prefer Subcutaneous Atezolizumab

March 22nd 2024

Patients with non–small cell lung cancer treated on the IMscin002 trial preferred subcutaneous atezolizumab vs the intravenous formulation.

FDA Green Lights Fluorouracil Safety Label Update Regarding Use in Patients With DPD Deficiency

March 21st 2024

The FDA has approved safety label changes for fluorouracil products to include information regarding the agent’s use in patients with DPD.

First-Line Pembrolizumab Plus Olaparib Maintenance Misses Survival End Points in Metastatic Nonsquamous NSCLC

March 21st 2024

Pembrolizumab plus olaparib as first-line maintenance therapy did not improve survival in patients with metastatic nonsquamous non–small cell lung cancer.

Exploratory Analysis Shows Perioperative Nivolumab Confers Benefit in Resectable NSCLC, Irrespective of Neoadjuvant Treatment Cycles

March 20th 2024

Perioperative nivolumab improved responses in resectable non–small cell lung cancer, irrespective of the number of neoadjuvant treatment cycles completed.

NXP800 Under Further Investigation in Platinum-Resistant, ARID1A-Mutated Ovarian Cancer

March 19th 2024

A phase 1b trial is investigating the novel GCN2 kinase activator NXP800 in patients with platinum-resistant, ARID1A-mutated ovarian cancer.

Liquid Nitrogen–Based Cryoablation Leads to High RFS Rate in Low-Risk, Early-Stage Breast Cancer

March 19th 2024

Liquid nitrogen–based cryoablation elicited a 5-year local RFS rate of 96.39% in patients with low-risk, early-stage breast cancer.

Tunlametinib Wins Approval in China for NRAS+ Advanced Melanoma After PD-1/PD-L1 Therapy

March 18th 2024

China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.

Social Determinants of Health Linked With Varying Cervical Cancer Rates in the US

March 16th 2024

Social determinants of health were associated with geographical variations in the rates of cervical cancer in the United States.

FDA ODAC Committee Votes in Favor of Benefit-Risk Profile of Ide-Cel in Early R/R Myeloma

March 15th 2024

The FDA’s Oncologic Drugs Advisory Committee voted in favor of idecabtagene vicleucel for patients with early relapsed/refractory myeloma.

FDA ODAC Committee Votes Unanimously in Favor of Benefit-Risk Profile of Cilta-Cel in Early R/R Myeloma

March 15th 2024

The FDA’s Oncologic Drugs Advisory Committee voted in favor of ciltacabtagene autoleucel for patients with early relapsed/refractory myeloma.

QOL Remains a Key Goal of the Use of Radiation in Rectal Cancer

March 14th 2024

Nina Sanford, MD, discusses how radiation could help improve QOL for patients with rectal cancer and situations when radiation or surgery could be omitted.

Japanese Approval Sought for Datopotamab Deruxtecan in Pretreated HR+/HER2– Advanced Breast Cancer

March 14th 2024

A new drug application seeking the approval of Dato-DXd for pretreated HR-positive, HER2-negative advanced breast cancer has been filed in Japan.

First-Line Niraparib Maintenance Is Not Associated With Worse HRQOL in Advanced Ovarian Cancer

March 13th 2024

First-line niraparib maintenance was not associated with worsened health-related quality of life outcomes vs placebo in advanced ovarian cancer.

FDA Accepts NDA for Ensartinib in Metastatic ALK+ NSCLC

March 13th 2024

The FDA has accepted a new drug application for ensartinib in metastatic ALK-positive non–small cell lung cancer.

FDA Grants Orphan Drug Designation to LYT-200 in AML

March 13th 2024

The FDA has granted orphan drug designation to LYT-200 for the treatment of acute myeloid leukemia.

TNO155 Plus Spartalizumab or Ribociclib Elicits Disease Control, Is Safe in Advanced Solid Tumors

March 12th 2024

TNO155 plus spartalizumab or ribociclib was well tolerated and demonstrated disease control in patients with advanced solid tumors.

FDA Lifts Partial Clinical Hold on Trial Evaluating NX-2127 in R/R B-Cell Malignancies

March 11th 2024

The FDA has lifted a partial clinical hold on a phase 1 trial evaluating NX-2127 in relapsed/refractory B-cell malignancies