Chris Ryan

The FDA has granted priority review to the new drug application for avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.

The FDA has granted regenerative medicine advanced therapy and fast track designations to equecabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma.

Adding trilaciclib to FOLFOXIRI and bevacizumab led to statistically significant reductions in instances of severe neutropenia during induction and duration of severe neutropenia in cycles 1 to 4. However, the combination failed to improve antitumor activity vs placebo plus FOLFOXIRI/bevacizumab in patients with metastatic colorectal cancer.

Idecabtagene vicleucel improved progression-free survival compared with standard combination regimens in patients with relapsed/refractory multiple myeloma after 2 to 4 prior lines of therapy and who were refractory to their last regimen, according to results from the phase 3 KarMMa-3 trial.

Elevation Oncology is pausing development of the human anti–HER3 IgG2 monoclonal antibody seribantumab, along with the phase 2 CRESTONE trial investigating the agent, in patients with advanced solid tumors harboring NRG1 fusions.

The CAR T-cell therapy brexucabtagene autoleucel produced a median overall survival of 26 months in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

FDA approvals in recent years have started to carve out a role for immunotherapy in the frontline treatment of patients with small cell lung cancer.

The World Health Organization has released new framework guidelines with the goal of saving 2.5 million lives from breast cancer by 2040 through a combination of early detection, timely diagnosis, and comprehensive management.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.

The combination of pembrolizumab plus carboplatin and paclitaxel demonstrated a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in the first-line treatment of patients with stage III/IV or recurrent endometrial cancer.

The FDA has granted orphan drug exclusivity to sodium thiosulfate injection, which is indicated to reduce the risk of platinum-induced ototoxicity in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.

Ciltacabtagene autoleucel demonstrated a significant improvement in progression-free survival in patients with relapsed/lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.

Magenta Therapeutics has voluntarily paused enrollment for a phase 1/2 trial evaluating the antibody-drug conjugate MGTA-117 in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome following the death of a patient.

The CAR T-cell therapy lisocabtagene maraleucel induced complete responses in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic leukemia.

The combination of avutometinib and defactinib elicited responses in patients with recurrent low-grade serous ovarian cancer, according to data from a planned interim analysis of the registration-directed phase 2 RAMP-201 trial.

Merck is discontinuing the phase 3 KEYNOTE-991 trial evaluating pembrolizumab plus enzalutamide and androgen deprivation therapy vs placebo plus enzalutamide/ADT in patients with metastatic hormone-sensitive prostate cancer due to futility.

Bavituximab in combination with pembrolizumab produced responses in patients with previously untreated advanced hepatocellular carcinoma.

Second-line ripretinib produced a clinical benefit in patients with advanced gastrointestinal stromal tumor harboring KIT exon 11 and 17/18 mutations who progressed on or were intolerant to imatinib.

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.